{ "release_id": "c7fb95f1d15a7d13", "id": "maternal:invu-remote-monitoring", "owner": "maternal", "kind": "product", "slug": "invu-remote-monitoring", "name": "INVU by Nuvo (maternal-fetal monitoring belt)", "aliases": [ "INVU", "Invu by Nuvo" ], "atlases": [ "maternal" ], "summary_plain": "A belt with sensors, worn on the abdomen, that shows the baby's heart rate, the mother's heart rate and contractions. FDA cleared it in 2021 for pregnant women in their 32nd week of gestation (or later) with a single baby, for use in a clinic or by the woman at home when a doctor orders it, for the kind of heart-rate check done before labour (a non-stress test). A device named PregSense (2020), which the FDA 2021 summary for INVU points to for heart-rate performance, was cleared for a five-minute heart-rate recording only. The FDA wording does not name use during labour, and the labelling states the system does not prevent early labour or early birth.", "summary_technical": "Three 510(k) clearances (K191401 is filed here only because the K210025 summary says INVU's heart-rate performance was addressed in it; no FDA document read calls PregSense an earlier name of INVU): K191401 (PregSense, 2020-03-27: fetal and maternal heart rate, five-minute use, antepartum, singleton, 32nd week or later, not for non-stress testing, not for labour or suspected preterm labour), K210025 (INVU by Nuvo, 2021-05-28: adds uterine activity and antepartum fetal surveillance including non-stress testing; prescription, physician order, facility or home) and K221046 (Invu by Nuvo, 2022-05-06: Special 510(k) for sensor-band material and software changes, same indication). The labelling states the system does not prevent preterm labour or preterm birth. In the K210025 uterine-activity study INVU agreed with the intrauterine catheter more often than a tocodynamometer did (84.80% against 37.50%) but had a higher false positive rate (24.28% against 10.69%). The FDA text does not use the word remote.", "editorial_state": "draft", "last_substantive_edit": "2026-10-14", "last_evidence_check": "2026-10-14", "next_review_due": null, "identifiers": [], "navigation": { "maternal": { "life-stage": [ "pregnancy" ], "care-area": [ "fetal-development" ] } }, "payload": { "subtype": "device", "model_or_formulation": "INVU Sensor Band and the INVU by Nuvo maternal-fetal monitor with mobile and web software, as named in the FDA indications for use", "version": "Clearances filed here: INVU by Nuvo (K210025, 2021), Invu by Nuvo (K221046, 2022) and, because the K210025 summary points to it for heart-rate performance, PregSense (K191401, 2020). US labelling only.", "intended_use_snapshots": [ "maternal:fda-510k-summary-k191401-2026-10-14", "maternal:fda-510k-summary-k210025-2026-10-14", "maternal:fda-510k-summary-k221046-2026-10-14" ] }, "content_digest": "4b163ffc9e9ca261b735e720bcdc20e7a282aaffcf8841f422addd2759279855", "review": { "content_digest": "4b163ffc9e9ca261b735e720bcdc20e7a282aaffcf8841f422addd2759279855", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-fda-k191401-indication", "owner": "maternal", "subject_entity_id": "maternal:invu-remote-monitoring", "category": "regulatory", "statement": "FDA cleared PregSense (Nuvo-Group Ltd) under 510(k) K191401 on 2020-03-27. The K210025 summary for INVU by Nuvo says INVU's heart-rate performance was addressed in K191401. The cleared use is as a maternal-fetal monitor that measures and displays fetal and maternal heart rate, for pregnant women who need documentation of fetal heart rate activity and are in their 32nd week of gestation (or later) with a singleton pregnancy, for a maximum of five minutes, in the antepartum period, used by healthcare professionals in health care facilities and by the patient at home on the order of a physician. It is not intended for critical care, for labouring patients or patients hospitalised for or suspected to have preterm labour, or for antepartum monitoring such as non-stress testing.", "context": { "id": "maternal:ctx-fda-k191401-singleton-32w-antepartum-record", "label": "Pregnant women in their 32nd week or later with a singleton pregnancy who need documentation of fetal heart rate, five-minute antepartum recording (US labelling of K191401)", "recipient": "mixed", "population": "Pregnant women with a singleton pregnancy in their 32nd week of gestation (or later) who need documentation of fetal heart rate activity. The device shows fetal and maternal heart rate. Not for critical care, labouring patients or those hospitalised for or suspected to have preterm labour, and not for antepartum monitoring such as non-stress testing.", "care_setting": "Health care facilities, or the patient's home on the order of a physician", "geography": "United States (FDA labelling)", "life_stage_note": "Antepartum period, 32nd week of gestation or later (the FDA summary elsewhere writes more than 32 weeks)", "life_stage_terms": { "maternal": [ "pregnancy" ] }, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable; this is the cleared indication for use", "eligibility": { "inclusion": [ "Singleton pregnancy", "32nd week of gestation or later", "Needs documentation of fetal heart rate activity" ], "exclusion": [ "Critical care situations", "Laboring patients", "Patients hospitalized for or suspected to have preterm labor" ] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "Clearance is not approval. PregSense is filed under the INVU product only because of one sentence in FDA's K210025 summary, which says INVU's heart-rate performance was addressed in K191401; no FDA document read says that PregSense is an earlier name of INVU, and this record does not show that the two are identical. This clearance does not cover uterine activity or non-stress testing. Only the clearance letter, the indications, the 510(k) summary sections cited here and the openFDA record were read.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Clearance letter, page 1, reference block", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k191401-2026-10-14", "retrieved_at": "2026-10-14T18:25:46Z", "content_hash": "9cd66bdd253a39b5188242f6743b4daef4ed2f6db4797e1dcca6e75f9aa2f6f2", "source_effective_date": "2020-03-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k191401", "source_type": "regulator", "title": "FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191401", "identifiers": [ { "scheme": "fda-510k", "value": "K191401", "normalized_value": "K191401", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2020-03-27", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 1", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k191401-2026-10-14", "retrieved_at": "2026-10-14T18:25:46Z", "content_hash": "9cd66bdd253a39b5188242f6743b4daef4ed2f6db4797e1dcca6e75f9aa2f6f2", "source_effective_date": "2020-03-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k191401", "source_type": "regulator", "title": "FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191401", "identifiers": [ { "scheme": "fda-510k", "value": "K191401", "normalized_value": "K191401", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2020-03-27", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 2, fragment 1 of 3", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k191401-2026-10-14", "retrieved_at": "2026-10-14T18:25:46Z", "content_hash": "9cd66bdd253a39b5188242f6743b4daef4ed2f6db4797e1dcca6e75f9aa2f6f2", "source_effective_date": "2020-03-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k191401", "source_type": "regulator", "title": "FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191401", "identifiers": [ { "scheme": "fda-510k", "value": "K191401", "normalized_value": "K191401", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2020-03-27", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 2, fragment 2 of 3", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k191401-2026-10-14", "retrieved_at": "2026-10-14T18:25:46Z", "content_hash": "9cd66bdd253a39b5188242f6743b4daef4ed2f6db4797e1dcca6e75f9aa2f6f2", "source_effective_date": "2020-03-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k191401", "source_type": "regulator", "title": "FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191401", "identifiers": [ { "scheme": "fda-510k", "value": "K191401", "normalized_value": "K191401", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2020-03-27", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 2, fragment 3 of 3", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k191401-2026-10-14", "retrieved_at": "2026-10-14T18:25:46Z", "content_hash": "9cd66bdd253a39b5188242f6743b4daef4ed2f6db4797e1dcca6e75f9aa2f6f2", "source_effective_date": "2020-03-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k191401", "source_type": "regulator", "title": "FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191401", "identifiers": [ { "scheme": "fda-510k", "value": "K191401", "normalized_value": "K191401", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2020-03-27", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 3, fragment 1 of 2", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k191401-2026-10-14", "retrieved_at": "2026-10-14T18:25:46Z", "content_hash": "9cd66bdd253a39b5188242f6743b4daef4ed2f6db4797e1dcca6e75f9aa2f6f2", "source_effective_date": "2020-03-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k191401", "source_type": "regulator", "title": "FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191401", "identifiers": [ { "scheme": "fda-510k", "value": "K191401", "normalized_value": "K191401", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2020-03-27", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 3, fragment 2 of 2", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k191401-2026-10-14", "retrieved_at": "2026-10-14T18:25:46Z", "content_hash": "9cd66bdd253a39b5188242f6743b4daef4ed2f6db4797e1dcca6e75f9aa2f6f2", "source_effective_date": "2020-03-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k191401", "source_type": "regulator", "title": "FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191401", "identifiers": [ { "scheme": "fda-510k", "value": "K191401", "normalized_value": "K191401", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2020-03-27", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 4, fragment 1 of 2", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k191401-2026-10-14", "retrieved_at": "2026-10-14T18:25:46Z", "content_hash": "9cd66bdd253a39b5188242f6743b4daef4ed2f6db4797e1dcca6e75f9aa2f6f2", "source_effective_date": "2020-03-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k191401", "source_type": "regulator", "title": "FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191401", "identifiers": [ { "scheme": "fda-510k", "value": "K191401", "normalized_value": "K191401", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2020-03-27", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 4, fragment 2 of 2", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k191401-2026-10-14", "retrieved_at": "2026-10-14T18:25:46Z", "content_hash": "9cd66bdd253a39b5188242f6743b4daef4ed2f6db4797e1dcca6e75f9aa2f6f2", "source_effective_date": "2020-03-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k191401", "source_type": "regulator", "title": "FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191401", "identifiers": [ { "scheme": "fda-510k", "value": "K191401", "normalized_value": "K191401", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2020-03-27", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 5", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k191401-2026-10-14", "retrieved_at": "2026-10-14T18:25:46Z", "content_hash": "9cd66bdd253a39b5188242f6743b4daef4ed2f6db4797e1dcca6e75f9aa2f6f2", "source_effective_date": "2020-03-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k191401", "source_type": "regulator", "title": "FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191401", "identifiers": [ { "scheme": "fda-510k", "value": "K191401", "normalized_value": "K191401", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2020-03-27", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].decision_date", "applicability_note": "openFDA 510(k) record.", "snapshot": { "id": "maternal:openfda-510k-k191401-2026-10-14", "retrieved_at": "2026-10-14T18:25:31Z", "content_hash": "9595d35abf52cc81583d6b515024104efbf52f7260408c1c39a66ddf1db2f9be", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k191401", "source_type": "regulator", "title": "FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191401", "identifiers": [ { "scheme": "fda-510k", "value": "K191401", "normalized_value": "K191401", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2020-03-27", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].decision_description", "applicability_note": "openFDA 510(k) record.", "snapshot": { "id": "maternal:openfda-510k-k191401-2026-10-14", "retrieved_at": "2026-10-14T18:25:31Z", "content_hash": "9595d35abf52cc81583d6b515024104efbf52f7260408c1c39a66ddf1db2f9be", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k191401", "source_type": "regulator", "title": "FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191401", "identifiers": [ { "scheme": "fda-510k", "value": "K191401", "normalized_value": "K191401", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2020-03-27", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].product_code", "applicability_note": "openFDA 510(k) record.", "snapshot": { "id": "maternal:openfda-510k-k191401-2026-10-14", "retrieved_at": "2026-10-14T18:25:31Z", "content_hash": "9595d35abf52cc81583d6b515024104efbf52f7260408c1c39a66ddf1db2f9be", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k191401", "source_type": "regulator", "title": "FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191401", "identifiers": [ { "scheme": "fda-510k", "value": "K191401", "normalized_value": "K191401", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2020-03-27", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].openfda.regulation_number", "applicability_note": "openFDA 510(k) record.", "snapshot": { "id": "maternal:openfda-510k-k191401-2026-10-14", "retrieved_at": "2026-10-14T18:25:31Z", "content_hash": "9595d35abf52cc81583d6b515024104efbf52f7260408c1c39a66ddf1db2f9be", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k191401", "source_type": "regulator", "title": "FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191401", "identifiers": [ { "scheme": "fda-510k", "value": "K191401", "normalized_value": "K191401", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2020-03-27", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].k_number", "applicability_note": "openFDA 510(k) record.", "snapshot": { "id": "maternal:openfda-510k-k191401-2026-10-14", "retrieved_at": "2026-10-14T18:25:31Z", "content_hash": "9595d35abf52cc81583d6b515024104efbf52f7260408c1c39a66ddf1db2f9be", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k191401", "source_type": "regulator", "title": "FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191401", "identifiers": [ { "scheme": "fda-510k", "value": "K191401", "normalized_value": "K191401", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2020-03-27", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k191401.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "510(k) Summary, Clinical Performance Data, paragraph 1", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:25:43Z", "content_hash": "4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c", "source_effective_date": "2021-05-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } } ], "review": { "content_digest": "c335e39abed56bea2e3b9584a6ac00763e082dc8312253c24479216e956a366c", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-fda-k191401-indication.json" }, { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-fda-k210025-indication", "owner": "maternal", "subject_entity_id": "maternal:invu-remote-monitoring", "category": "regulatory", "statement": "FDA cleared INVU by Nuvo (Nuvo-Group Ltd) under 510(k) K210025 on 2021-05-28 as a maternal-fetal monitor that non-invasively measures and displays fetal heart rate, maternal heart rate and uterine activity. It is indicated for pregnant women in their 32nd week of gestation (or later) with a singleton pregnancy, for use by healthcare professionals in health care facilities and by the patient at home, on the order of a physician, and for antepartum fetal surveillance (non-stress testing). The labelling states that the system does not prevent the onset of preterm labour and will not prevent preterm birth.", "context": { "id": "maternal:ctx-fda-k210025-singleton-32w-nst", "label": "Pregnant women in their 32nd week or later with a singleton pregnancy, antepartum surveillance (non-stress testing), hospital or home on physician order (US labelling of K210025 and K221046)", "recipient": "mixed", "population": "Pregnant women with a singleton pregnancy in their 32nd week of gestation (or later). The device shows fetal heart rate, maternal heart rate (mother) and uterine activity (mother). Indicated for antepartum fetal surveillance (non-stress testing). The labelling states it does not prevent the onset of preterm labour or preterm birth.", "care_setting": "Health care facilities, or the patient's home on the order of a physician", "geography": "United States (FDA labelling)", "life_stage_note": "Antepartum period, 32nd week of gestation or later", "life_stage_terms": { "maternal": [ "pregnancy" ] }, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable; this is the cleared indication for use", "eligibility": { "inclusion": [ "Singleton pregnancy", "32nd week of gestation or later" ], "exclusion": [ "Not stated in the parts of the source that were read." ] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "Clearance is not approval. The cleared use is antepartum surveillance on a physician's order; the FDA text does not name labour (intrapartum) monitoring and does not use the word remote. Prescription use is on the order of a physician. The summary says the fetal and maternal heart rate performance was addressed in the earlier K191401, and the new clinical data it describes concern uterine activity (see the performance claim). The text for singleton pregnancies reads 32nd week of gestation (or later) in the indication and at least 32 gestational weeks or greater than 32 weeks in the comparison text; the bound is not turned into days here. Only the clearance letter, the indications, the 510(k) summary sections cited here and the openFDA record were read.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Clearance letter, page 1, reference block", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:25:43Z", "content_hash": "4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c", "source_effective_date": "2021-05-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 1, fragment 1 of 2", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:25:43Z", "content_hash": "4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c", "source_effective_date": "2021-05-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 1, fragment 2 of 2", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:25:43Z", "content_hash": "4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c", "source_effective_date": "2021-05-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 3", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:25:43Z", "content_hash": "4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c", "source_effective_date": "2021-05-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 4, fragment 1 of 2", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:25:43Z", "content_hash": "4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c", "source_effective_date": "2021-05-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 4, fragment 2 of 2", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:25:43Z", "content_hash": "4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c", "source_effective_date": "2021-05-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 5", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:25:43Z", "content_hash": "4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c", "source_effective_date": "2021-05-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 6", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:25:43Z", "content_hash": "4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c", "source_effective_date": "2021-05-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "510(k) Summary, Clinical Performance Data, paragraph 1", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:25:43Z", "content_hash": "4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c", "source_effective_date": "2021-05-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].decision_date", "applicability_note": "openFDA 510(k) record.", "snapshot": { "id": "maternal:openfda-510k-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:18:30Z", "content_hash": "378fab5fb70e7d254c228bfb5e227b8cc02697e93d41f562deb3e8a90709acb3", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].decision_description", "applicability_note": "openFDA 510(k) record.", "snapshot": { "id": "maternal:openfda-510k-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:18:30Z", "content_hash": "378fab5fb70e7d254c228bfb5e227b8cc02697e93d41f562deb3e8a90709acb3", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].product_code", "applicability_note": "openFDA 510(k) record.", "snapshot": { "id": "maternal:openfda-510k-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:18:30Z", "content_hash": "378fab5fb70e7d254c228bfb5e227b8cc02697e93d41f562deb3e8a90709acb3", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].openfda.regulation_number", "applicability_note": "openFDA 510(k) record.", "snapshot": { "id": "maternal:openfda-510k-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:18:30Z", "content_hash": "378fab5fb70e7d254c228bfb5e227b8cc02697e93d41f562deb3e8a90709acb3", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].k_number", "applicability_note": "openFDA 510(k) record.", "snapshot": { "id": "maternal:openfda-510k-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:18:30Z", "content_hash": "378fab5fb70e7d254c228bfb5e227b8cc02697e93d41f562deb3e8a90709acb3", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } } ], "review": { "content_digest": "e74faff354e9e19f551c8bdb5b61564f0656864ae9e7c8abf6ce01d8fa725a5a", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-fda-k210025-indication.json" }, { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-fda-k221046-indication", "owner": "maternal", "subject_entity_id": "maternal:invu-remote-monitoring", "category": "regulatory", "statement": "FDA cleared Invu by Nuvo (Nuvo-Group Ltd) under Special 510(k) K221046 on 2022-05-06. The indication for use is worded as in K210025: a maternal-fetal monitor that measures and displays fetal heart rate, maternal heart rate and uterine activity, for pregnant women in their 32nd week of gestation (or later) with a singleton pregnancy, used by healthcare professionals in health care facilities and by the patient at home on the order of a physician, indicated for antepartum fetal surveillance (non-stress testing), and the labelling states it does not prevent preterm labour or preterm birth. The summary describes changes to the sensor band (material of manufacture, buckles, belt material, band length, and the charging LED) and states that no modifications affect sensor position or performance.", "context": { "id": "maternal:ctx-fda-k210025-singleton-32w-nst", "label": "Pregnant women in their 32nd week or later with a singleton pregnancy, antepartum surveillance (non-stress testing), hospital or home on physician order (US labelling of K210025 and K221046)", "recipient": "mixed", "population": "Pregnant women with a singleton pregnancy in their 32nd week of gestation (or later). The device shows fetal heart rate, maternal heart rate (mother) and uterine activity (mother). Indicated for antepartum fetal surveillance (non-stress testing). The labelling states it does not prevent the onset of preterm labour or preterm birth.", "care_setting": "Health care facilities, or the patient's home on the order of a physician", "geography": "United States (FDA labelling)", "life_stage_note": "Antepartum period, 32nd week of gestation or later", "life_stage_terms": { "maternal": [ "pregnancy" ] }, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable; this is the cleared indication for use", "eligibility": { "inclusion": [ "Singleton pregnancy", "32nd week of gestation or later" ], "exclusion": [ "Not stated in the parts of the source that were read." ] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "This is a Special 510(k) for changes to a device already cleared under K210025, with no new indication. Clearance is not approval. The FDA text does not name labour (intrapartum) monitoring and does not use the word remote. Only the clearance letter, the indications, the 510(k) summary sections cited here and the openFDA record were read.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Clearance letter, page 1, reference block", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k221046-2026-10-14", "retrieved_at": "2026-10-14T18:25:44Z", "content_hash": "3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f", "source_effective_date": "2022-05-06", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k221046", "source_type": "regulator", "title": "FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221046", "identifiers": [ { "scheme": "fda-510k", "value": "K221046", "normalized_value": "K221046", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2022-05-06", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 1, fragment 1 of 2", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k221046-2026-10-14", "retrieved_at": "2026-10-14T18:25:44Z", "content_hash": "3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f", "source_effective_date": "2022-05-06", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k221046", "source_type": "regulator", "title": "FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221046", "identifiers": [ { "scheme": "fda-510k", "value": "K221046", "normalized_value": "K221046", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2022-05-06", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 1, fragment 2 of 2", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k221046-2026-10-14", "retrieved_at": "2026-10-14T18:25:44Z", "content_hash": "3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f", "source_effective_date": "2022-05-06", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k221046", "source_type": "regulator", "title": "FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221046", "identifiers": [ { "scheme": "fda-510k", "value": "K221046", "normalized_value": "K221046", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2022-05-06", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 3", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k221046-2026-10-14", "retrieved_at": "2026-10-14T18:25:44Z", "content_hash": "3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f", "source_effective_date": "2022-05-06", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k221046", "source_type": "regulator", "title": "FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221046", "identifiers": [ { "scheme": "fda-510k", "value": "K221046", "normalized_value": "K221046", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2022-05-06", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 4, fragment 1 of 2", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k221046-2026-10-14", "retrieved_at": "2026-10-14T18:25:44Z", "content_hash": "3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f", "source_effective_date": "2022-05-06", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k221046", "source_type": "regulator", "title": "FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221046", "identifiers": [ { "scheme": "fda-510k", "value": "K221046", "normalized_value": "K221046", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2022-05-06", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 4, fragment 2 of 2", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k221046-2026-10-14", "retrieved_at": "2026-10-14T18:25:44Z", "content_hash": "3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f", "source_effective_date": "2022-05-06", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k221046", "source_type": "regulator", "title": "FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221046", "identifiers": [ { "scheme": "fda-510k", "value": "K221046", "normalized_value": "K221046", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2022-05-06", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 5", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k221046-2026-10-14", "retrieved_at": "2026-10-14T18:25:44Z", "content_hash": "3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f", "source_effective_date": "2022-05-06", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k221046", "source_type": "regulator", "title": "FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221046", "identifiers": [ { "scheme": "fda-510k", "value": "K221046", "normalized_value": "K221046", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2022-05-06", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form, paragraph 6", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k221046-2026-10-14", "retrieved_at": "2026-10-14T18:25:44Z", "content_hash": "3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f", "source_effective_date": "2022-05-06", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k221046", "source_type": "regulator", "title": "FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221046", "identifiers": [ { "scheme": "fda-510k", "value": "K221046", "normalized_value": "K221046", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2022-05-06", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "510(k) Summary, Substantial Equivalence, paragraph 3, sentence 1", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k221046-2026-10-14", "retrieved_at": "2026-10-14T18:25:44Z", "content_hash": "3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f", "source_effective_date": "2022-05-06", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k221046", "source_type": "regulator", "title": "FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221046", "identifiers": [ { "scheme": "fda-510k", "value": "K221046", "normalized_value": "K221046", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2022-05-06", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "510(k) Summary, Substantial Equivalence, paragraph 3, sentence 3", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k221046-2026-10-14", "retrieved_at": "2026-10-14T18:25:44Z", "content_hash": "3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f", "source_effective_date": "2022-05-06", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k221046", "source_type": "regulator", "title": "FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221046", "identifiers": [ { "scheme": "fda-510k", "value": "K221046", "normalized_value": "K221046", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2022-05-06", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "510(k) Summary, Substantial Equivalence, paragraph 3, sentence 2", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k221046-2026-10-14", "retrieved_at": "2026-10-14T18:25:44Z", "content_hash": "3c09eae5bca896e95bf9a021b4c7b3890f4aeaca2dfd2456f5fc2b06ad28e66f", "source_effective_date": "2022-05-06", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k221046", "source_type": "regulator", "title": "FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221046", "identifiers": [ { "scheme": "fda-510k", "value": "K221046", "normalized_value": "K221046", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2022-05-06", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].decision_date", "applicability_note": "openFDA 510(k) record.", "snapshot": { "id": "maternal:openfda-510k-k221046-2026-10-14", "retrieved_at": "2026-10-14T18:18:31Z", "content_hash": "09fd6bf9ee6bb35d8f665698e693297d9b934c1d409a486b38e62358241c74fb", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k221046", "source_type": "regulator", "title": "FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221046", "identifiers": [ { "scheme": "fda-510k", "value": "K221046", "normalized_value": "K221046", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2022-05-06", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].decision_description", "applicability_note": "openFDA 510(k) record.", "snapshot": { "id": "maternal:openfda-510k-k221046-2026-10-14", "retrieved_at": "2026-10-14T18:18:31Z", "content_hash": "09fd6bf9ee6bb35d8f665698e693297d9b934c1d409a486b38e62358241c74fb", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k221046", "source_type": "regulator", "title": "FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221046", "identifiers": [ { "scheme": "fda-510k", "value": "K221046", "normalized_value": "K221046", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2022-05-06", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].product_code", "applicability_note": "openFDA 510(k) record.", "snapshot": { "id": "maternal:openfda-510k-k221046-2026-10-14", "retrieved_at": "2026-10-14T18:18:31Z", "content_hash": "09fd6bf9ee6bb35d8f665698e693297d9b934c1d409a486b38e62358241c74fb", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k221046", "source_type": "regulator", "title": "FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221046", "identifiers": [ { "scheme": "fda-510k", "value": "K221046", "normalized_value": "K221046", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2022-05-06", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].openfda.regulation_number", "applicability_note": "openFDA 510(k) record.", "snapshot": { "id": "maternal:openfda-510k-k221046-2026-10-14", "retrieved_at": "2026-10-14T18:18:31Z", "content_hash": "09fd6bf9ee6bb35d8f665698e693297d9b934c1d409a486b38e62358241c74fb", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k221046", "source_type": "regulator", "title": "FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221046", "identifiers": [ { "scheme": "fda-510k", "value": "K221046", "normalized_value": "K221046", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2022-05-06", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].k_number", "applicability_note": "openFDA 510(k) record.", "snapshot": { "id": "maternal:openfda-510k-k221046-2026-10-14", "retrieved_at": "2026-10-14T18:18:31Z", "content_hash": "09fd6bf9ee6bb35d8f665698e693297d9b934c1d409a486b38e62358241c74fb", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k221046", "source_type": "regulator", "title": "FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221046", "identifiers": [ { "scheme": "fda-510k", "value": "K221046", "normalized_value": "K221046", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2022-05-06", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].clearance_type", "applicability_note": "openFDA 510(k) record.", "snapshot": { "id": "maternal:openfda-510k-k221046-2026-10-14", "retrieved_at": "2026-10-14T18:18:31Z", "content_hash": "09fd6bf9ee6bb35d8f665698e693297d9b934c1d409a486b38e62358241c74fb", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k221046", "source_type": "regulator", "title": "FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221046", "identifiers": [ { "scheme": "fda-510k", "value": "K221046", "normalized_value": "K221046", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2022-05-06", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k221046.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } } ], "review": { "content_digest": "f7f196fa9c65c29cf2df52d584d337a6afab1263aa4508164ec082b5ce8d51ab", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-fda-k221046-indication.json" }, { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-invu-uterine-activity-performance", "owner": "maternal", "subject_entity_id": "maternal:invu-remote-monitoring", "category": "descriptive", "statement": "The 510(k) summary for K210025 describes a pivotal study of uterine activity in two phases, a training phase (N=40) and a validation phase (N=80). INVU met the performance goal that the lower 95% bound of the positive percent agreement exceed 75%, with a positive percent agreement of 84.80% (95% CI 81.58% to 88.02%) against the intrauterine pressure catheter (IUPC), which the summary calls the gold standard, compared with 37.50% (95% CI 28.23% to 46.77%) for the tocodynamometer (TOCO), the standard of care. INVU had the higher false positive rate against IUPC: 24.28% (95% CI 20.46% to 28.11%) against 10.69% (95% CI 5.65% to 15.72%) for TOCO. The summary concludes that INVU is comparable to the standard of care TOCO device and meets the required accuracy for its intended use in pregnant women aged 18 to 50 of at least 32 weeks of gestation.", "context": { "id": "maternal:ctx-invu-ua-validation-pregnant-18-50-32w", "label": "Pregnant women aged 18 to 50 years with at least 32 weeks of gestation, uterine activity validation study (INVU, K210025)", "recipient": "maternal", "population": "Pregnant women aged 18 to 50 years with at least 32 weeks of gestation, in a pivotal study that recorded uterine activity with INVU, with the intrauterine pressure catheter (IUPC, called the gold standard in the summary) and with a tocodynamometer (TOCO, called the standard of care). The measured quantity, uterine contractions, belongs to the mother.", "care_setting": "Clinical study described in an FDA 510(k) summary; setting not described in the parts read", "geography": "Not stated in the summary", "life_stage_note": "Pregnancy, at least 32 weeks of gestation (the summary writes populations of pregnant women ages between 18-50 of at least 32 weeks gestation)", "life_stage_terms": { "maternal": [ "pregnancy" ] }, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Training phase of 40 and validation phase of 80 (N as the summary writes it)", "eligibility": { "inclusion": [], "exclusion": [ "Not stated in the parts of the source that were read." ] } }, "evidence_stage": "observational", "certainty": "not_assessed", "certainty_method": null, "limitations": "This is the manufacturer's submission summary as released by FDA, not a published trial, and it reports one uterine-activity study. The false positive rate of INVU was higher than that of TOCO, and the summary does not explain what a false positive means in practice. Agreement with a catheter is not the same as an effect on outcomes. The summary says the performance for fetal and maternal heart rate was addressed in K191401, and this record does not report those figures. Only the summary pages read were used.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "510(k) Summary, Clinical Performance Data, paragraph 2, sentence 3", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:25:43Z", "content_hash": "4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c", "source_effective_date": "2021-05-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "510(k) Summary, Clinical Performance Data, paragraph 4, sentence 3", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:25:43Z", "content_hash": "4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c", "source_effective_date": "2021-05-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "510(k) Summary, Clinical Performance Data, paragraph 4, sentence 4", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:25:43Z", "content_hash": "4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c", "source_effective_date": "2021-05-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "510(k) Summary, Clinical Performance Data, paragraph 4, sentence 5, fragment 1 of 2", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:25:43Z", "content_hash": "4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c", "source_effective_date": "2021-05-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "510(k) Summary, Clinical Performance Data, paragraph 4, sentence 5, fragment 2 of 2", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:25:43Z", "content_hash": "4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c", "source_effective_date": "2021-05-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "510(k) Summary, Clinical Performance Data, paragraph 4, sentence 6, fragment 2 of 2", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:25:43Z", "content_hash": "4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c", "source_effective_date": "2021-05-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "510(k) Summary, Clinical Performance Data, paragraph 4, sentence 2", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:25:43Z", "content_hash": "4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c", "source_effective_date": "2021-05-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } }, { "evidence_role": "context", "locator": "510(k) Summary, Clinical Performance Data, paragraph 4, sentence 6, fragment 1 of 2", "applicability_note": "Frames the population or setting. FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k210025-2026-10-14", "retrieved_at": "2026-10-14T18:25:43Z", "content_hash": "4cd012735c9483f91aeacbe179c02b1c1f0ab604dc8dbe040cc2aaab873b011c", "source_effective_date": "2021-05-28", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k210025", "source_type": "regulator", "title": "FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210025", "identifiers": [ { "scheme": "fda-510k", "value": "K210025", "normalized_value": "K210025", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2021-05-28", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-14. The openFDA device 510(k) JSON record (dataset last updated 2026-10-05) gives the decision date, product code and decision. The 510(k) summary PDF from accessdata.fda.gov holds FDA's clearance letter, the Indications for Use form and the submitter's own 510(k) Summary.", "reuse_basis": "The openFDA content is public domain under a CC0 1.0 dedication (https://open.fda.gov/license/). The raw openFDA JSON is committed at research/snapshots/mf-openfda-510k-k210025.json; it holds the applicant's contact details exactly as FDA publishes them, and records here do not repeat them. The 510(k) summary PDF is the submitter's text released by FDA, so only short quotations are used and its bytes are not committed. FDA website content is not copyrighted unless otherwise noted (https://www.fda.gov/about-fda/about-website/website-policies).", "public_text": "quote" } } ], "review": { "content_digest": "3f866cce5e9797f413c2720a653c9b4c8bf72d13dbf6aa3f792e4d42eb9d5bd3", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-invu-uterine-activity-performance.json" } ], "decisions": [ { "type": "regulatory_decision", "id": "maternal:regdec-fda-k191401", "product_id": "maternal:invu-remote-monitoring", "product_version": "PregSense, as cleared under K191401", "indication": "A maternal-fetal monitor that non-invasively measures and displays fetal and maternal heart rate, indicated for pregnant women who need documentation of fetal heart rate activity, in their 32nd week of gestation (or later), with a singleton pregnancy, for a maximum of five minutes, in the antepartum period. Not intended for critical care, laboring patients or patients hospitalized for or suspected to have preterm labor, and not for antepartum monitoring such as non-stress testing.", "context_id": "maternal:ctx-fda-k191401-singleton-32w-antepartum-record", "jurisdictions": [ "US" ], "jurisdiction_note": "United States", "authority_id": "core:fda", "decision_type": "clearance", "recall_class": null, "submission_id": "K191401", "pathway": "510k", "product_code": "LQK", "device_class": "II", "decision_date": "2020-03-27", "valid_to": null, "claim_id": "maternal:claim-fda-k191401-indication" }, { "type": "regulatory_decision", "id": "maternal:regdec-fda-k210025", "product_id": "maternal:invu-remote-monitoring", "product_version": "INVU by Nuvo, as cleared under K210025", "indication": "A maternal-fetal monitor that non-invasively measures and displays fetal heart rate, maternal heart rate and uterine activity, indicated for pregnant women in their 32nd week of gestation (or later) with a singleton pregnancy, for use by healthcare professionals in health care facilities and by the patient at home on the order of a physician, and for antepartum fetal surveillance (non-stress testing). The system does not prevent the onset of preterm labor nor will it prevent preterm birth.", "context_id": "maternal:ctx-fda-k210025-singleton-32w-nst", "jurisdictions": [ "US" ], "jurisdiction_note": "United States", "authority_id": "core:fda", "decision_type": "clearance", "recall_class": null, "submission_id": "K210025", "pathway": "510k", "product_code": "LQK", "device_class": "II", "decision_date": "2021-05-28", "valid_to": null, "claim_id": "maternal:claim-fda-k210025-indication" }, { "type": "regulatory_decision", "id": "maternal:regdec-fda-k221046", "product_id": "maternal:invu-remote-monitoring", "product_version": "Invu by Nuvo, as cleared under Special 510(k) K221046", "indication": "The same indication as K210025: a maternal-fetal monitor that measures and displays fetal heart rate, maternal heart rate and uterine activity, for pregnant women in their 32nd week of gestation (or later) with a singleton pregnancy, in health care facilities or at home on the order of a physician, for antepartum fetal surveillance (non-stress testing). The cleared changes concern the sensor band, accessories and software.", "context_id": "maternal:ctx-fda-k210025-singleton-32w-nst", "jurisdictions": [ "US" ], "jurisdiction_note": "United States", "authority_id": "core:fda", "decision_type": "clearance", "recall_class": null, "submission_id": "K221046", "pathway": "510k", "product_code": "LQK", "device_class": "II", "decision_date": "2022-05-06", "valid_to": null, "claim_id": "maternal:claim-fda-k221046-indication" } ], "milestones": [], "relationships": { "outgoing": [ { "predicate": "uses_technology", "label": "Fetal heart rate from abdominal sensors", "clinical_claim_not_fact": false, "family": "navigation", "other_entity_id": "maternal:electronic-fetal-monitoring", "other_entity_in_atlas": true, "claim_id": "maternal:claim-fda-k210025-indication", "evidence": null, "primary": false, "role": null, "valid_from": null, "valid_to": null }, { "predicate": "part_of", "label": "Filed under this front", "clinical_claim_not_fact": false, "family": "navigation", "other_entity_id": "maternal:front-imaging-and-monitoring", "other_entity_in_atlas": true, "claim_id": null, "evidence": null, "primary": true, "role": null, "valid_from": null, "valid_to": null } ], "incoming": [] }, "page_path": "products/invu-remote-monitoring/", "context_path": "api/v1/context/maternal--invu-remote-monitoring.md" }