{ "release_id": "c7fb95f1d15a7d13", "id": "maternal:novii-wireless-patch", "owner": "maternal", "kind": "product", "slug": "novii-wireless-patch", "name": "Novii wireless patch system (fetal heart rate from the abdomen)", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "A wireless pod and patch of electrodes stuck to the mother's abdomen that shows the baby's heart rate, the mother's heart rate and contractions without belts. FDA cleared the first version in 2014 for women in labour at more than 36 completed weeks with a single baby, and cleared Novii+ in 2023 for use before and during labour in women with a single baby at 34 weeks and 0/7 days or later, in a clinical setting. Both are described as for healthcare professionals in a clinical setting; the FDA text does not mention use at home.", "summary_technical": "Two 510(k) clearances (substantial equivalence, not approval): K140862 (Monica Novii Wireless Patch System, Monica Healthcare, decision 2014-08-27, intrapartum, more than 36 completed weeks, singleton) and K231964 (Novii+ Wireless Patch System, Datex Ohmeda, decision 2023-12-08, antepartum and intrapartum, 34 weeks and 0/7 days and greater, singleton). K231964 names K140862 as its predicate. The product code differs between FDA's K140862 letter (HGM) and the openFDA record (OSP); both are shown on the decision. Clinical data summarised by FDA: 31 patients in labour (K140862) and 30 subjects at 34+0 to 36+6 weeks (K231964).", "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", "childbirth" ], "care-area": [ "fetal-development" ] } }, "payload": { "subtype": "device", "model_or_formulation": "Novii Pod with Novii Patch (surface electrodes) and Novii Interface, as named in the FDA indications for use; the later version is Novii+", "version": "Cleared versions: Monica Novii Wireless Patch System (K140862, 2014) and Novii+ Wireless Patch System (K231964, 2023). US labelling only.", "intended_use_snapshots": [ "maternal:fda-510k-summary-k140862-2026-10-14", "maternal:fda-510k-summary-k231964-2026-10-14" ] }, "content_digest": "4f027543cb9d86a9f9f1cab866e239c3b3d104dac65bab82f39367887c400ccc", "review": { "content_digest": "4f027543cb9d86a9f9f1cab866e239c3b3d104dac65bab82f39367887c400ccc", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-fda-k140862-indication", "owner": "maternal", "subject_entity_id": "maternal:novii-wireless-patch", "category": "regulatory", "statement": "FDA cleared the Monica Novii Wireless Patch System (Monica Healthcare Ltd) under 510(k) K140862 on 2014-08-27. The cleared use is as an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate, uterine activity and maternal heart rate from abdominal surface electrodes, on women at more than 36 completed weeks, in labour, with singleton pregnancies, used by healthcare professionals in a clinical setting. The indication names intrapartum use in a clinical setting; it does not name antepartum use or use at home.", "context": { "id": "maternal:ctx-fda-k140862-labour-singleton", "label": "Women in labour with a singleton pregnancy at more than 36 completed weeks, monitored by healthcare professionals in a clinical setting (US labelling of K140862)", "recipient": "mixed", "population": "Pregnant women in labour, with singleton pregnancies at more than 36 completed weeks, wearing abdominal surface electrodes. The device shows the fetal heart rate (fetus), uterine activity and the maternal heart rate (mother).", "care_setting": "Clinical setting, used by healthcare professionals", "geography": "United States (FDA labelling)", "life_stage_note": "Labour, singleton pregnancy at more than 36 completed weeks (the FDA text says >36 completed weeks; whether 36 weeks 0 days counts is not stated)", "life_stage_terms": { "maternal": [ "childbirth" ] }, "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": [ "In labour", "Singleton pregnancy", "More than 36 completed weeks of gestation" ], "exclusion": [ "Not stated in the parts of the source that were read." ] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "Clearance means FDA found the device substantially equivalent to earlier devices; it is not an approval and not a recommendation to use the device for any one woman. The sources disagree on the product code: FDA's clearance letter gives HGM (21 CFR 884.2740, class II), while the openFDA record gives OSP (21 CFR 884.2720). Both are shown and are not reconciled here; the decision records the letter's code. The 510(k) summary describes a comparison with the predicate monitor in 31 patients in labour; this record gives no accuracy numbers. 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-k140862-2026-10-14", "retrieved_at": "2026-10-14T18:25:40Z", "content_hash": "40e34b8362d7788495f85253bc16dc4429c7c8b49b2d04e7fac05f753f9bfe0a", "source_effective_date": "2014-08-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k140862", "source_type": "regulator", "title": "FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140862", "identifiers": [ { "scheme": "fda-510k", "value": "K140862", "normalized_value": "K140862", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2014-08-27", "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-k140862.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 statement, paragraph 1, sentence 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-k140862-2026-10-14", "retrieved_at": "2026-10-14T18:25:40Z", "content_hash": "40e34b8362d7788495f85253bc16dc4429c7c8b49b2d04e7fac05f753f9bfe0a", "source_effective_date": "2014-08-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k140862", "source_type": "regulator", "title": "FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140862", "identifiers": [ { "scheme": "fda-510k", "value": "K140862", "normalized_value": "K140862", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2014-08-27", "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-k140862.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 statement, paragraph 1, sentence 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-k140862-2026-10-14", "retrieved_at": "2026-10-14T18:25:40Z", "content_hash": "40e34b8362d7788495f85253bc16dc4429c7c8b49b2d04e7fac05f753f9bfe0a", "source_effective_date": "2014-08-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k140862", "source_type": "regulator", "title": "FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140862", "identifiers": [ { "scheme": "fda-510k", "value": "K140862", "normalized_value": "K140862", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2014-08-27", "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-k140862.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 statement, paragraph 1, 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-k140862-2026-10-14", "retrieved_at": "2026-10-14T18:25:40Z", "content_hash": "40e34b8362d7788495f85253bc16dc4429c7c8b49b2d04e7fac05f753f9bfe0a", "source_effective_date": "2014-08-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k140862", "source_type": "regulator", "title": "FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140862", "identifiers": [ { "scheme": "fda-510k", "value": "K140862", "normalized_value": "K140862", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2014-08-27", "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-k140862.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 statement, 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-k140862-2026-10-14", "retrieved_at": "2026-10-14T18:25:40Z", "content_hash": "40e34b8362d7788495f85253bc16dc4429c7c8b49b2d04e7fac05f753f9bfe0a", "source_effective_date": "2014-08-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k140862", "source_type": "regulator", "title": "FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140862", "identifiers": [ { "scheme": "fda-510k", "value": "K140862", "normalized_value": "K140862", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2014-08-27", "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-k140862.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 Testing", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k140862-2026-10-14", "retrieved_at": "2026-10-14T18:25:40Z", "content_hash": "40e34b8362d7788495f85253bc16dc4429c7c8b49b2d04e7fac05f753f9bfe0a", "source_effective_date": "2014-08-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k140862", "source_type": "regulator", "title": "FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140862", "identifiers": [ { "scheme": "fda-510k", "value": "K140862", "normalized_value": "K140862", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2014-08-27", "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-k140862.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 Testing, paragraph 2, sentence 1 continued", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k140862-2026-10-14", "retrieved_at": "2026-10-14T18:25:40Z", "content_hash": "40e34b8362d7788495f85253bc16dc4429c7c8b49b2d04e7fac05f753f9bfe0a", "source_effective_date": "2014-08-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k140862", "source_type": "regulator", "title": "FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140862", "identifiers": [ { "scheme": "fda-510k", "value": "K140862", "normalized_value": "K140862", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2014-08-27", "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-k140862.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-k140862-2026-10-14", "retrieved_at": "2026-10-14T18:18:30Z", "content_hash": "f62188048a514d60e43bd34f9b941360243716d8375795b9a5d5647a007a9bfa", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k140862", "source_type": "regulator", "title": "FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140862", "identifiers": [ { "scheme": "fda-510k", "value": "K140862", "normalized_value": "K140862", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2014-08-27", "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-k140862.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-k140862-2026-10-14", "retrieved_at": "2026-10-14T18:18:30Z", "content_hash": "f62188048a514d60e43bd34f9b941360243716d8375795b9a5d5647a007a9bfa", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k140862", "source_type": "regulator", "title": "FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140862", "identifiers": [ { "scheme": "fda-510k", "value": "K140862", "normalized_value": "K140862", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2014-08-27", "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-k140862.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-k140862-2026-10-14", "retrieved_at": "2026-10-14T18:18:30Z", "content_hash": "f62188048a514d60e43bd34f9b941360243716d8375795b9a5d5647a007a9bfa", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k140862", "source_type": "regulator", "title": "FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140862", "identifiers": [ { "scheme": "fda-510k", "value": "K140862", "normalized_value": "K140862", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2014-08-27", "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-k140862.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": "results[0].product_code", "applicability_note": "Frames the population or setting. openFDA 510(k) record.", "snapshot": { "id": "maternal:openfda-510k-k140862-2026-10-14", "retrieved_at": "2026-10-14T18:18:30Z", "content_hash": "f62188048a514d60e43bd34f9b941360243716d8375795b9a5d5647a007a9bfa", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k140862", "source_type": "regulator", "title": "FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140862", "identifiers": [ { "scheme": "fda-510k", "value": "K140862", "normalized_value": "K140862", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2014-08-27", "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-k140862.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": "results[0].openfda.regulation_number", "applicability_note": "Frames the population or setting. openFDA 510(k) record.", "snapshot": { "id": "maternal:openfda-510k-k140862-2026-10-14", "retrieved_at": "2026-10-14T18:18:30Z", "content_hash": "f62188048a514d60e43bd34f9b941360243716d8375795b9a5d5647a007a9bfa", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k140862", "source_type": "regulator", "title": "FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140862", "identifiers": [ { "scheme": "fda-510k", "value": "K140862", "normalized_value": "K140862", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2014-08-27", "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-k140862.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": "bccc7a055762b5ec5c36a8df48628eec330ac971355c661860e3ecf6369f484f", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-fda-k140862-indication.json" }, { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-fda-k231964-indication", "owner": "maternal", "subject_entity_id": "maternal:novii-wireless-patch", "category": "regulatory", "statement": "FDA cleared the Novii+ Wireless Patch System (Datex Ohmeda) under 510(k) K231964 on 2023-12-08. The cleared use is as an antepartum and intrapartum maternal/fetal monitor that non-invasively measures fetal heart rate, uterine activity and maternal heart rate from abdominal surface electrodes, on women at 34 weeks and 0/7 days and greater with singleton pregnancies, used by healthcare professionals in a clinical setting. The 510(k) summary names the Monica Novii Wireless Patch system (K140862) as its predicate device.", "context": { "id": "maternal:ctx-fda-k231964-singleton-34w0d-plus", "label": "Women at 34 weeks 0 days or later with a singleton pregnancy, antepartum or intrapartum, monitored in a clinical setting (US labelling of K231964)", "recipient": "mixed", "population": "Pregnant women at 34 weeks and 0/7 days and greater with singleton pregnancies, wearing abdominal surface electrodes. The device shows the fetal heart rate (fetus), uterine activity and the maternal heart rate (mother).", "care_setting": "Clinical setting, used by healthcare professionals", "geography": "United States (FDA labelling)", "life_stage_note": "Antepartum and intrapartum, from 34 weeks 0 days of gestation", "life_stage_terms": { "maternal": [ "pregnancy", "childbirth" ] }, "gestational_age_min_days": 238, "gestational_age_max_days": null, "gestational_age_basis": "at_measurement", "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", "34 weeks and 0/7 days of gestation or greater" ], "exclusion": [ "Not stated in the parts of the source that were read." ] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "Clearance means FDA found the device substantially equivalent to a predicate; it is not an approval. The indication names a clinical setting and healthcare professionals; it does not name use at home. The clinical study described in the summary enrolled 30 subjects between 34+0 and 36+6 weeks (see the performance claim). 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-k231964-2026-10-14", "retrieved_at": "2026-10-14T18:25:42Z", "content_hash": "7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a", "source_effective_date": "2023-12-08", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k231964", "source_type": "regulator", "title": "FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231964", "identifiers": [ { "scheme": "fda-510k", "value": "K231964", "normalized_value": "K231964", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-12-08", "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-k231964.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, Indications for Use, 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-k231964-2026-10-14", "retrieved_at": "2026-10-14T18:25:42Z", "content_hash": "7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a", "source_effective_date": "2023-12-08", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k231964", "source_type": "regulator", "title": "FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231964", "identifiers": [ { "scheme": "fda-510k", "value": "K231964", "normalized_value": "K231964", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-12-08", "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-k231964.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, Indications for Use, 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-k231964-2026-10-14", "retrieved_at": "2026-10-14T18:25:42Z", "content_hash": "7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a", "source_effective_date": "2023-12-08", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k231964", "source_type": "regulator", "title": "FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231964", "identifiers": [ { "scheme": "fda-510k", "value": "K231964", "normalized_value": "K231964", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-12-08", "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-k231964.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, Indications for Use, last paragraph", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k231964-2026-10-14", "retrieved_at": "2026-10-14T18:25:42Z", "content_hash": "7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a", "source_effective_date": "2023-12-08", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k231964", "source_type": "regulator", "title": "FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231964", "identifiers": [ { "scheme": "fda-510k", "value": "K231964", "normalized_value": "K231964", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-12-08", "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-k231964.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, predicate device row", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k231964-2026-10-14", "retrieved_at": "2026-10-14T18:25:42Z", "content_hash": "7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a", "source_effective_date": "2023-12-08", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k231964", "source_type": "regulator", "title": "FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231964", "identifiers": [ { "scheme": "fda-510k", "value": "K231964", "normalized_value": "K231964", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-12-08", "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-k231964.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-k231964-2026-10-14", "retrieved_at": "2026-10-14T18:18:30Z", "content_hash": "68faf7d19b287ce3e9715c5e7eee2301b2222cd6ef4365e6f7b3757158bf7cb6", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k231964", "source_type": "regulator", "title": "FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231964", "identifiers": [ { "scheme": "fda-510k", "value": "K231964", "normalized_value": "K231964", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-12-08", "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-k231964.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-k231964-2026-10-14", "retrieved_at": "2026-10-14T18:18:30Z", "content_hash": "68faf7d19b287ce3e9715c5e7eee2301b2222cd6ef4365e6f7b3757158bf7cb6", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k231964", "source_type": "regulator", "title": "FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231964", "identifiers": [ { "scheme": "fda-510k", "value": "K231964", "normalized_value": "K231964", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-12-08", "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-k231964.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-k231964-2026-10-14", "retrieved_at": "2026-10-14T18:18:30Z", "content_hash": "68faf7d19b287ce3e9715c5e7eee2301b2222cd6ef4365e6f7b3757158bf7cb6", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k231964", "source_type": "regulator", "title": "FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231964", "identifiers": [ { "scheme": "fda-510k", "value": "K231964", "normalized_value": "K231964", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-12-08", "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-k231964.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-k231964-2026-10-14", "retrieved_at": "2026-10-14T18:18:30Z", "content_hash": "68faf7d19b287ce3e9715c5e7eee2301b2222cd6ef4365e6f7b3757158bf7cb6", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k231964", "source_type": "regulator", "title": "FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231964", "identifiers": [ { "scheme": "fda-510k", "value": "K231964", "normalized_value": "K231964", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-12-08", "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-k231964.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-k231964-2026-10-14", "retrieved_at": "2026-10-14T18:18:30Z", "content_hash": "68faf7d19b287ce3e9715c5e7eee2301b2222cd6ef4365e6f7b3757158bf7cb6", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k231964", "source_type": "regulator", "title": "FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231964", "identifiers": [ { "scheme": "fda-510k", "value": "K231964", "normalized_value": "K231964", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-12-08", "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-k231964.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": "ac1561bf326863a1e716b6f54803806b1ad615d762fbace6203d372f2e49cc10", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-fda-k231964-indication.json" }, { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-novii-plus-clinical-performance", "owner": "maternal", "subject_entity_id": "maternal:novii-wireless-patch", "category": "descriptive", "statement": "The 510(k) summary for Novii+ (K231964) describes a clinical study of 30 subjects enrolled between 34 weeks + 0/7 days and 36 weeks + 6/7 days: 14 with threatened preterm labour (not in labour) and 16 with preterm labour and delivery. The mean percent agreement for fetal heart rate between Novii+ and the predicate Doppler fetal heart rate was 88.08%, with a 95% lower confidence limit of 83.45%, above the 80% threshold set to demonstrate equivalence.", "context": { "id": "maternal:ctx-novii-plus-study-34w0d-36w6d", "label": "Women at 34 weeks 0 days to 36 weeks 6 days, threatened preterm labour or preterm labour and delivery (Novii+ clinical study in K231964)", "recipient": "mixed", "population": "30 subjects enrolled between 34 weeks + 0/7 days and 36 weeks + 6/7 days of gestation: 14 with threatened preterm labour (not in labour) and 16 with preterm labour and delivery. Compared against Doppler fetal heart rate, tocodynamometer uterine activity and pulse-oximeter maternal heart rate.", "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, 34 weeks 0 days to 36 weeks 6 days", "life_stage_terms": { "maternal": [ "pregnancy", "childbirth" ] }, "gestational_age_min_days": 238, "gestational_age_max_days": 258, "gestational_age_basis": "at_enrolment", "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not stated in the parts read", "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. The summary reports similar agreement tests for maternal heart rate and uterine activity that this record does not repeat. The study covers 34+0 to 36+6 weeks only, and 30 subjects. Percent agreement is not the same as clinical outcome benefit. 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, Summary of Clinical testing, 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-k231964-2026-10-14", "retrieved_at": "2026-10-14T18:25:42Z", "content_hash": "7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a", "source_effective_date": "2023-12-08", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k231964", "source_type": "regulator", "title": "FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231964", "identifiers": [ { "scheme": "fda-510k", "value": "K231964", "normalized_value": "K231964", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-12-08", "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-k231964.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, Summary of Clinical testing, paragraph 3, sentence 1 continued", "applicability_note": "FDA 510(k) summary PDF as released by FDA; the submitter's text, short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k231964-2026-10-14", "retrieved_at": "2026-10-14T18:25:42Z", "content_hash": "7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a", "source_effective_date": "2023-12-08", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k231964", "source_type": "regulator", "title": "FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231964", "identifiers": [ { "scheme": "fda-510k", "value": "K231964", "normalized_value": "K231964", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-12-08", "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-k231964.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, Summary of Clinical testing, FHR, 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-k231964-2026-10-14", "retrieved_at": "2026-10-14T18:25:42Z", "content_hash": "7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a", "source_effective_date": "2023-12-08", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k231964", "source_type": "regulator", "title": "FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231964", "identifiers": [ { "scheme": "fda-510k", "value": "K231964", "normalized_value": "K231964", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-12-08", "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-k231964.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, Summary of Clinical testing, FHR, 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-k231964-2026-10-14", "retrieved_at": "2026-10-14T18:25:42Z", "content_hash": "7fcdc868b387925e686998b6cbe6633f8b8a2c3303bf7b8cf3d4678ac9bb323a", "source_effective_date": "2023-12-08", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k231964", "source_type": "regulator", "title": "FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231964", "identifiers": [ { "scheme": "fda-510k", "value": "K231964", "normalized_value": "K231964", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-12-08", "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-k231964.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": "378949e0f115233e011781f951c478a2e122e37f16210a39b6f368bcdfc5e8a0", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-novii-plus-clinical-performance.json" } ], "decisions": [ { "type": "regulatory_decision", "id": "maternal:regdec-fda-k140862", "product_id": "maternal:novii-wireless-patch", "product_version": "Monica Novii Wireless Patch System, as cleared under K140862", "indication": "An intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate, uterine activity and maternal heart rate from abdominal surface electrodes, indicated for women at more than 36 completed weeks, in labour, with singleton pregnancies, for use by healthcare professionals in a clinical setting.", "context_id": "maternal:ctx-fda-k140862-labour-singleton", "jurisdictions": [ "US" ], "jurisdiction_note": "United States", "authority_id": "core:fda", "decision_type": "clearance", "recall_class": null, "submission_id": "K140862", "pathway": "510k", "product_code": "HGM", "device_class": "II", "decision_date": "2014-08-27", "valid_to": null, "claim_id": "maternal:claim-fda-k140862-indication" }, { "type": "regulatory_decision", "id": "maternal:regdec-fda-k231964", "product_id": "maternal:novii-wireless-patch", "product_version": "Novii+ Wireless Patch System, as cleared under K231964", "indication": "An antepartum and intrapartum maternal/fetal monitor that non-invasively measures fetal heart rate, uterine activity and maternal heart rate from abdominal surface electrodes, indicated for women at 34 weeks and 0/7 days and greater with singleton pregnancies, for use by healthcare professionals in a clinical setting.", "context_id": "maternal:ctx-fda-k231964-singleton-34w0d-plus", "jurisdictions": [ "US" ], "jurisdiction_note": "United States", "authority_id": "core:fda", "decision_type": "clearance", "recall_class": null, "submission_id": "K231964", "pathway": "510k", "product_code": "HGM", "device_class": "II", "decision_date": "2023-12-08", "valid_to": null, "claim_id": "maternal:claim-fda-k231964-indication" } ], "milestones": [], "relationships": { "outgoing": [ { "predicate": "uses_technology", "label": "Abdominal ECG-based fetal heart rate", "clinical_claim_not_fact": false, "family": "navigation", "other_entity_id": "maternal:electronic-fetal-monitoring", "other_entity_in_atlas": true, "claim_id": null, "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/novii-wireless-patch/", "context_path": "api/v1/context/maternal--novii-wireless-patch.md" }