{ "release_id": "c7fb95f1d15a7d13", "id": "maternal:jada-system", "owner": "maternal", "kind": "product", "slug": "jada-system", "name": "Jada System (intrauterine vacuum device)", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "A device placed inside the uterus (womb) after birth that uses vacuum, instead of a filled balloon, to press on the uterine walls. In the United States, FDA cleared it in 2020, an updated version in 2021 and a version from a new applicant in 2026 through the 510(k) route, which means FDA found it substantially equivalent to a device already on the market. Its cleared use is \"control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted\".", "summary_technical": "Alydia Health (K201199, K212757) and Organon, LLC (K253642). 510(k) K201199, decision Substantially Equivalent on 2020-08-28, traditional clearance, product code OQY, regulation 21 CFR 884.4530, class II; Special 510(k) K212757, 2021-09-30, for an updated version with modifications to manufacturability, packaging and user experience; and Traditional 510(k) K253642, 2026-05-15, for Jada System (Jada-2002), with K212757 as predicate. All three state the same indication, quoted on this page. The K201199 summary names an earlier balloon device, cleared under K170622, as the predicate and says the compressed intrauterine loop is inserted transvaginally. The clearances cover that use only. Whether further Jada clearances exist beyond the three read here was not checked.", "editorial_state": "draft", "last_substantive_edit": "2026-10-15", "last_evidence_check": "2026-10-15", "next_review_due": null, "identifiers": [ { "scheme": "fda-product-code", "value": "OQY", "normalized_value": "OQY", "match": "broad", "version": null, "label": null, "from_source": false } ], "navigation": { "maternal": { "life-stage": [ "childbirth", "postpartum" ], "care-area": [ "postpartum-recovery" ] } }, "payload": { "subtype": "device", "model_or_formulation": "Jada System (Jada® System in the FDA documents), as named in openFDA 510(k) records K201199 and K212757", "version": "Original version as cleared under K201199 on 2020-08-28, updated version as cleared under K212757 on 2021-09-30, and Jada-2002 as cleared under K253642 on 2026-05-15", "intended_use_snapshots": [ "maternal:openfda-510k-k201199-2026-10-15", "maternal:fda-510k-summary-k201199-2026-10-15", "maternal:openfda-510k-k212757-2026-10-15", "maternal:fda-510k-summary-k212757-2026-10-15", "maternal:openfda-510k-k253642-2026-10-15", "maternal:fda-510k-summary-k253642-2026-10-15" ] }, "content_digest": "bf924e7adb5c89eb128d8c76568143f33a8f2593df58f6587c1edcbfce322670", "review": { "content_digest": "bf924e7adb5c89eb128d8c76568143f33a8f2593df58f6587c1edcbfce322670", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-fda-k201199-indication", "owner": "maternal", "subject_entity_id": "maternal:jada-system", "category": "regulatory", "statement": "FDA cleared the Jada System from applicant Alydia Health under 510(k) K201199, with the decision Substantially Equivalent dated 2020-08-28. The Indications for Use state that the device is \"intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted\". The product code is OQY (openFDA name: Intrauterine Tamponade Balloon), the regulation is 21 CFR 884.4530 and the device class is II. The 510(k) summary names the Bakri Postpartum Balloon (K170622) as the predicate and says the Jada System uses vacuum to affect tamponade on the uterine walls, where the predicate uses the fluid pressure of an expanding balloon.", "context": { "id": "maternal:ctx-fda-k201199-us", "label": "Abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted, US 510(k) clearance of the Jada System (K201199)", "recipient": "maternal", "population": "Women with abnormal postpartum uterine bleeding or hemorrhage for whom conservative management is warranted. The cleared use is control and treatment of that bleeding (510(k) Indications for Use). It is not cleared for other uses.", "care_setting": "Not stated in the source", "geography": "United States (FDA clearance)", "life_stage_note": "After birth, abnormal postpartum uterine bleeding", "life_stage_terms": { "maternal": [ "childbirth", "postpartum" ] }, "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 (regulatory context)", "eligibility": { "inclusion": [ "Postpartum women with abnormal uterine bleeding or hemorrhage when conservative management is warranted" ], "exclusion": [ "Any other use: the clearance covers only the stated indication" ] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "Clearance means FDA found the device substantially equivalent to a legally marketed predicate; it is not an approval and not a recommendation to use the device for any woman. Only the clearance letter, the Indications for Use form, the 510(k) summary and the openFDA record were read; contraindications, warnings and performance data were not. The openFDA record is the dataset copy as of its update date.", "editorial_state": "draft", "checked_at": "2026-10-15", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "results[0].decision_date and results[0].decision_description", "applicability_note": "openFDA 510(k) JSON, CC0.", "snapshot": { "id": "maternal:openfda-510k-k201199-2026-10-15", "retrieved_at": "2026-10-15T13:49:17Z", "content_hash": "d6320d7d9ba80c9f4f3831e6c27410d5e205124215f9bb1a7d851518860c016b", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-k201199", "source_type": "regulator", "title": "FDA 510(k) premarket notification K201199: Jada System (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201199", "identifiers": [ { "scheme": "fda-510k", "value": "K201199", "normalized_value": "K201199", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201199.pdf), read as default pdftotext text, which gives the cleared indication.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k201199.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].product_code and results[0].openfda.device_name", "applicability_note": "openFDA 510(k) JSON, CC0.", "snapshot": { "id": "maternal:openfda-510k-k201199-2026-10-15", "retrieved_at": "2026-10-15T13:49:17Z", "content_hash": "d6320d7d9ba80c9f4f3831e6c27410d5e205124215f9bb1a7d851518860c016b", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-k201199", "source_type": "regulator", "title": "FDA 510(k) premarket notification K201199: Jada System (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201199", "identifiers": [ { "scheme": "fda-510k", "value": "K201199", "normalized_value": "K201199", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201199.pdf), read as default pdftotext text, which gives the cleared indication.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k201199.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form and section V", "applicability_note": "510(k) summary PDF released by FDA; short quotation.", "snapshot": { "id": "maternal:fda-510k-summary-k201199-2026-10-15", "retrieved_at": "2026-10-15T13:53:05Z", "content_hash": "e732bb54b770ec10af4bc60e70923156b554478b727c126ece4e7c403cb18f37", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-k201199", "source_type": "regulator", "title": "FDA 510(k) premarket notification K201199: Jada System (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201199", "identifiers": [ { "scheme": "fda-510k", "value": "K201199", "normalized_value": "K201199", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201199.pdf), read as default pdftotext text, which gives the cleared indication.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k201199.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Section VI, technological differences", "applicability_note": "510(k) summary PDF released by FDA; short quotation.", "snapshot": { "id": "maternal:fda-510k-summary-k201199-2026-10-15", "retrieved_at": "2026-10-15T13:53:05Z", "content_hash": "e732bb54b770ec10af4bc60e70923156b554478b727c126ece4e7c403cb18f37", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-k201199", "source_type": "regulator", "title": "FDA 510(k) premarket notification K201199: Jada System (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201199", "identifiers": [ { "scheme": "fda-510k", "value": "K201199", "normalized_value": "K201199", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201199.pdf), read as default pdftotext text, which gives the cleared indication.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k201199.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.", "public_text": "quote" } } ], "review": { "content_digest": "e5a961d1a5191856f33f8fcdfea67e00967af7b73c87c96da0ccdb7db7c3d293", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-fda-k201199-indication.json" }, { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-fda-k212757-indication", "owner": "maternal", "subject_entity_id": "maternal:jada-system", "category": "regulatory", "statement": "FDA cleared an updated Jada System from applicant Alydia Health under Special 510(k) K212757, with the decision Substantially Equivalent dated 2021-09-30. The Indications for Use are the same as for the earlier Jada System clearance: \"intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted\". The summary says the subject device is an updated version of the earlier Jada System with modifications to improve manufacturability, streamline packaging and improve user experience and aesthetics. The product code is OQY and the device class is II.", "context": { "id": "maternal:ctx-fda-k212757-us", "label": "Abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted, US 510(k) clearance of the updated Jada System (K212757)", "recipient": "maternal", "population": "The same population as the earlier Jada System clearance: women with abnormal postpartum uterine bleeding or hemorrhage for whom conservative management is warranted. FDA treated the indication as identical to that of the earlier Jada System.", "care_setting": "Not stated in the source", "geography": "United States (FDA clearance)", "life_stage_note": "After birth, abnormal postpartum uterine bleeding", "life_stage_terms": { "maternal": [ "childbirth", "postpartum" ] }, "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 (regulatory context)", "eligibility": { "inclusion": [ "Postpartum women with abnormal uterine bleeding or hemorrhage when conservative management is warranted" ], "exclusion": [ "Any other use: the clearance covers only the stated indication" ] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "Clearance means FDA found the device substantially equivalent to a legally marketed predicate; it is not an approval and not a recommendation to use the device for any woman. Only the clearance letter, the Indications for Use form, the 510(k) summary and the openFDA record were read; contraindications, warnings and performance data were not. The openFDA record is the dataset copy as of its update date.", "editorial_state": "draft", "checked_at": "2026-10-15", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "results[0].decision_date and results[0].decision_description", "applicability_note": "openFDA 510(k) JSON, CC0.", "snapshot": { "id": "maternal:openfda-510k-k212757-2026-10-15", "retrieved_at": "2026-10-15T13:49:18Z", "content_hash": "a48a6d679e7c0426a5f24578c369020c9d8de844ffd654998a9418477f40d64c", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-k212757", "source_type": "regulator", "title": "FDA 510(k) premarket notification K212757: Jada System (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212757", "identifiers": [ { "scheme": "fda-510k", "value": "K212757", "normalized_value": "K212757", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212757.pdf), read as default pdftotext text, which gives the cleared indication.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k212757.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].product_code and results[0].openfda.device_name", "applicability_note": "openFDA 510(k) JSON, CC0.", "snapshot": { "id": "maternal:openfda-510k-k212757-2026-10-15", "retrieved_at": "2026-10-15T13:49:18Z", "content_hash": "a48a6d679e7c0426a5f24578c369020c9d8de844ffd654998a9418477f40d64c", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-k212757", "source_type": "regulator", "title": "FDA 510(k) premarket notification K212757: Jada System (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212757", "identifiers": [ { "scheme": "fda-510k", "value": "K212757", "normalized_value": "K212757", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212757.pdf), read as default pdftotext text, which gives the cleared indication.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k212757.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Section V, Indications for Use", "applicability_note": "510(k) summary PDF released by FDA; short quotation.", "snapshot": { "id": "maternal:fda-510k-summary-k212757-2026-10-15", "retrieved_at": "2026-10-15T13:53:05Z", "content_hash": "708f770b0e7ca61e79cc88fc48023c9ebcfb593edb5650563e475c2234b6443c", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-k212757", "source_type": "regulator", "title": "FDA 510(k) premarket notification K212757: Jada System (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212757", "identifiers": [ { "scheme": "fda-510k", "value": "K212757", "normalized_value": "K212757", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212757.pdf), read as default pdftotext text, which gives the cleared indication.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k212757.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Section VI", "applicability_note": "510(k) summary PDF released by FDA; short quotation.", "snapshot": { "id": "maternal:fda-510k-summary-k212757-2026-10-15", "retrieved_at": "2026-10-15T13:53:05Z", "content_hash": "708f770b0e7ca61e79cc88fc48023c9ebcfb593edb5650563e475c2234b6443c", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-k212757", "source_type": "regulator", "title": "FDA 510(k) premarket notification K212757: Jada System (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K212757", "identifiers": [ { "scheme": "fda-510k", "value": "K212757", "normalized_value": "K212757", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212757.pdf), read as default pdftotext text, which gives the cleared indication.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k212757.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.", "public_text": "quote" } } ], "review": { "content_digest": "ed4a4f871d41042248fddf7590f5244d01ba760bff25d21e76f11592a3cf6d7f", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-fda-k212757-indication.json" }, { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-fda-k253642-indication", "owner": "maternal", "subject_entity_id": "maternal:jada-system", "category": "regulatory", "statement": "FDA cleared the Jada System (Jada-2002) from applicant Organon, LLC under Traditional 510(k) K253642, with the decision Substantially Equivalent dated 2026-05-15. The Indications for Use are the same as for the earlier Jada System clearances: \"intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted\". The summary names the Jada System cleared under K212757 as the predicate and says the subject and predicate have identical indications for use statements. The product code is OQY and the device class is II.", "context": { "id": "maternal:ctx-fda-k253642-us", "label": "Abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted, US 510(k) clearance of the Jada System (Jada-2002), K253642", "recipient": "maternal", "population": "The same population as the earlier Jada System clearances: women with abnormal postpartum uterine bleeding or hemorrhage for whom conservative management is warranted. FDA treated the indication as identical to that of the predicate, K212757.", "care_setting": "Not stated in the source", "geography": "United States (FDA clearance)", "life_stage_note": "After birth, abnormal postpartum uterine bleeding", "life_stage_terms": { "maternal": [ "childbirth", "postpartum" ] }, "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 (regulatory context)", "eligibility": { "inclusion": [ "Postpartum women with abnormal uterine bleeding or hemorrhage when conservative management is warranted" ], "exclusion": [ "Any other use: the clearance covers only the stated indication" ] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "Clearance means FDA found the device substantially equivalent to a legally marketed predicate; it is not an approval and not a recommendation to use the device for any woman. Only the clearance letter, the Indications for Use form, the 510(k) summary and the openFDA record were read; contraindications, warnings and performance data were not. The openFDA record is the dataset copy as of its update date.", "editorial_state": "draft", "checked_at": "2026-10-15", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "results[0].decision_date and results[0].decision_description", "applicability_note": "openFDA 510(k) JSON, CC0.", "snapshot": { "id": "maternal:openfda-510k-k253642-2026-10-15", "retrieved_at": "2026-10-15T14:46:48Z", "content_hash": "15454869ec8e2928768ccccdc4dfc98d7e89b6d77a56c650fc458b35c1fabac9", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-k253642", "source_type": "regulator", "title": "FDA 510(k) premarket notification K253642: Jada System (Jada-2002) (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253642", "identifiers": [ { "scheme": "fda-510k", "value": "K253642", "normalized_value": "K253642", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253642.pdf), read as default pdftotext text, which gives the cleared indication.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k253642.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "results[0].product_code and results[0].openfda.device_name", "applicability_note": "openFDA 510(k) JSON, CC0.", "snapshot": { "id": "maternal:openfda-510k-k253642-2026-10-15", "retrieved_at": "2026-10-15T14:46:48Z", "content_hash": "15454869ec8e2928768ccccdc4dfc98d7e89b6d77a56c650fc458b35c1fabac9", "source_effective_date": "2026-10-05", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-k253642", "source_type": "regulator", "title": "FDA 510(k) premarket notification K253642: Jada System (Jada-2002) (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253642", "identifiers": [ { "scheme": "fda-510k", "value": "K253642", "normalized_value": "K253642", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253642.pdf), read as default pdftotext text, which gives the cleared indication.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k253642.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form and section V", "applicability_note": "510(k) summary PDF released by FDA; short quotation.", "snapshot": { "id": "maternal:fda-510k-summary-k253642-2026-10-15", "retrieved_at": "2026-10-15T14:46:52Z", "content_hash": "83b50ee59392910ed046a9782225dfeeff9f431e0fc2e5e796375ec8e92b6bfa", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-k253642", "source_type": "regulator", "title": "FDA 510(k) premarket notification K253642: Jada System (Jada-2002) (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253642", "identifiers": [ { "scheme": "fda-510k", "value": "K253642", "normalized_value": "K253642", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253642.pdf), read as default pdftotext text, which gives the cleared indication.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k253642.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Predicate Device", "applicability_note": "510(k) summary PDF released by FDA; short quotation.", "snapshot": { "id": "maternal:fda-510k-summary-k253642-2026-10-15", "retrieved_at": "2026-10-15T14:46:52Z", "content_hash": "83b50ee59392910ed046a9782225dfeeff9f431e0fc2e5e796375ec8e92b6bfa", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-k253642", "source_type": "regulator", "title": "FDA 510(k) premarket notification K253642: Jada System (Jada-2002) (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253642", "identifiers": [ { "scheme": "fda-510k", "value": "K253642", "normalized_value": "K253642", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253642.pdf), read as default pdftotext text, which gives the cleared indication.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k253642.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Section VI", "applicability_note": "510(k) summary PDF released by FDA; short quotation.", "snapshot": { "id": "maternal:fda-510k-summary-k253642-2026-10-15", "retrieved_at": "2026-10-15T14:46:52Z", "content_hash": "83b50ee59392910ed046a9782225dfeeff9f431e0fc2e5e796375ec8e92b6bfa", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-k253642", "source_type": "regulator", "title": "FDA 510(k) premarket notification K253642: Jada System (Jada-2002) (openFDA record)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253642", "identifiers": [ { "scheme": "fda-510k", "value": "K253642", "normalized_value": "K253642", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. A second retrieval fetched the FDA clearance letter, Indications for Use form and 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253642.pdf), read as default pdftotext text, which gives the cleared indication.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the license page was fetched as mk-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mk-openfda-510k-k253642.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF is hash only; it is a submission summary released by FDA, and the FDA website policies page (mk-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says FDA website content is not copyrighted unless noted. Only short quotations are used.", "public_text": "quote" } } ], "review": { "content_digest": "a0caaf4d6d08d9abcbeac3beaf323aaea2f6d8ad94ca68a05f1a2414240aff9e", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-fda-k253642-indication.json" } ], "decisions": [ { "type": "regulatory_decision", "id": "maternal:regdec-fda-k201199", "product_id": "maternal:jada-system", "product_version": "Jada System as cleared under K201199 (traditional 510(k))", "indication": "Cleared intended use, as the Indications for Use word it: \"intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted\".", "context_id": "maternal:ctx-fda-k201199-us", "jurisdictions": [ "US" ], "jurisdiction_note": "United States", "authority_id": "core:fda", "decision_type": "clearance", "recall_class": null, "submission_id": "K201199", "pathway": "510k", "product_code": "OQY", "device_class": "II", "decision_date": "2020-08-28", "valid_to": null, "claim_id": "maternal:claim-fda-k201199-indication" }, { "type": "regulatory_decision", "id": "maternal:regdec-fda-k212757", "product_id": "maternal:jada-system", "product_version": "Updated Jada System as cleared under K212757 (special 510(k))", "indication": "Cleared intended use, identical to the earlier Jada System: \"intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted\".", "context_id": "maternal:ctx-fda-k212757-us", "jurisdictions": [ "US" ], "jurisdiction_note": "United States", "authority_id": "core:fda", "decision_type": "clearance", "recall_class": null, "submission_id": "K212757", "pathway": "510k", "product_code": "OQY", "device_class": "II", "decision_date": "2021-09-30", "valid_to": null, "claim_id": "maternal:claim-fda-k212757-indication" }, { "type": "regulatory_decision", "id": "maternal:regdec-fda-k253642", "product_id": "maternal:jada-system", "product_version": "Jada System (Jada-2002) as cleared under K253642 (traditional 510(k))", "indication": "Cleared intended use, identical to the earlier Jada System: \"intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted\".", "context_id": "maternal:ctx-fda-k253642-us", "jurisdictions": [ "US" ], "jurisdiction_note": "United States", "authority_id": "core:fda", "decision_type": "clearance", "recall_class": null, "submission_id": "K253642", "pathway": "510k", "product_code": "OQY", "device_class": "II", "decision_date": "2026-05-15", "valid_to": null, "claim_id": "maternal:claim-fda-k253642-indication" } ], "milestones": [], "relationships": { "outgoing": [ { "predicate": "related_to", "label": "Vacuum-induced tamponade", "clinical_claim_not_fact": false, "family": "navigation", "other_entity_id": "maternal:uterine-balloon-tamponade", "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-procedures-and-birth-care", "other_entity_in_atlas": true, "claim_id": null, "evidence": null, "primary": true, "role": null, "valid_from": null, "valid_to": null } ], "incoming": [] }, "page_path": "products/jada-system/", "context_path": "api/v1/context/maternal--jada-system.md" }