{
  "release_id": "fc5a600ec7387e71",
  "id": "maternal:bakri-postpartum-balloon",
  "owner": "maternal",
  "kind": "product",
  "slug": "bakri-postpartum-balloon",
  "name": "Bakri Postpartum Balloon",
  "aliases": [],
  "atlases": [
    "maternal"
  ],
  "summary_plain": "A silicone balloon on a catheter that is placed inside the uterus (womb) after birth and expanded with fluid so it presses on the uterine walls. In the United States the FDA cleared it, and a version with rapid-fill parts, in 2017 through the 510(k) route, which means FDA found it substantially equivalent to a device already on the market. Its cleared use is \"temporary control or reduction of postpartum uterine bleeding when conservative management is warranted\".",
  "summary_technical": "Cook Incorporated. Special 510(k) K170622, decision Substantially Equivalent on 2017-03-31, product code OQY, regulation 21 CFR 884.4530, class II, for the Bakri Postpartum Balloon and the Bakri Postpartum Balloon with Rapid Instillation Components. The indication for each is to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted. The summary names the earlier Bakri Postpartum Balloon (K062438) as the predicate and describes a tamponade balloon catheter with a balloon of 500 mL at most; that earlier clearance was not read. The clearance covers that use only.",
  "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": "Bakri Postpartum Balloon and Bakri Postpartum Balloon with Rapid Instillation Components, as named in openFDA 510(k) record K170622",
    "version": "As cleared under K170622 on 2017-03-31",
    "intended_use_snapshots": [
      "maternal:openfda-510k-k170622-2026-10-15",
      "maternal:fda-510k-summary-k170622-2026-10-15"
    ]
  },
  "content_digest": "a382949c445c194e786ca0952befab3095f8d20a98c3824a5c06c9f2e9332fd6",
  "review": {
    "content_digest": "a382949c445c194e786ca0952befab3095f8d20a98c3824a5c06c9f2e9332fd6",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [
    {
      "release_id": "fc5a600ec7387e71",
      "id": "maternal:claim-fda-k170622-indication",
      "owner": "maternal",
      "subject_entity_id": "maternal:bakri-postpartum-balloon",
      "category": "regulatory",
      "statement": "FDA cleared the Bakri Postpartum Balloon and the Bakri Postpartum Balloon with Rapid Instillation Components from applicant Cook Incorporated under Special 510(k) K170622, with the decision Substantially Equivalent dated 2017-03-31. The Indications for Use say each is \"intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted\". The product code is OQY (openFDA name: Intrauterine Tamponade Balloon) and the device class is II. The summary names the earlier Bakri Postpartum Balloon (K062438) as the predicate, describes it as a tamponade balloon catheter with a balloon of 500 mL at most, and says the Rapid Instillation version adds a dual check valve and tubing.",
      "context": {
        "id": "maternal:ctx-fda-k170622-us",
        "label": "Postpartum uterine bleeding when conservative management is warranted, US 510(k) clearance of the Bakri Postpartum Balloon (K170622)",
        "recipient": "maternal",
        "population": "Women with postpartum uterine bleeding for whom conservative management is warranted. The cleared use is temporary control or reduction of that bleeding (510(k) Indications for Use), for both the Bakri Postpartum Balloon and the version with Rapid Instillation Components. It is not cleared for other uses.",
        "care_setting": "Not stated in the source",
        "geography": "United States (FDA clearance)",
        "life_stage_note": "After birth, 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 uterine bleeding 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. The earlier clearance K062438 is named only as the predicate; it was not read.",
      "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-k170622-2026-10-15",
            "retrieved_at": "2026-10-15T13:49:18Z",
            "content_hash": "24015db0b7170f4e55abeefac14ed77e191e62f9191fcf0c9506f1b326955d33",
            "source_effective_date": "2026-10-05",
            "public_archive_url": null,
            "source_state": "current"
          },
          "source": {
            "id": "maternal:openfda-k170622",
            "source_type": "regulator",
            "title": "FDA 510(k) premarket notification K170622: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (openFDA record)",
            "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170622",
            "identifiers": [
              {
                "scheme": "fda-510k",
                "value": "K170622",
                "normalized_value": "K170622",
                "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/pdf17/K170622.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-k170622.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",
            "replaced_by": null,
            "retirement_note": null
          }
        },
        {
          "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-k170622-2026-10-15",
            "retrieved_at": "2026-10-15T13:49:18Z",
            "content_hash": "24015db0b7170f4e55abeefac14ed77e191e62f9191fcf0c9506f1b326955d33",
            "source_effective_date": "2026-10-05",
            "public_archive_url": null,
            "source_state": "current"
          },
          "source": {
            "id": "maternal:openfda-k170622",
            "source_type": "regulator",
            "title": "FDA 510(k) premarket notification K170622: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (openFDA record)",
            "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170622",
            "identifiers": [
              {
                "scheme": "fda-510k",
                "value": "K170622",
                "normalized_value": "K170622",
                "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/pdf17/K170622.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-k170622.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",
            "replaced_by": null,
            "retirement_note": null
          }
        },
        {
          "evidence_role": "supports",
          "locator": "Indications for Use form",
          "applicability_note": "510(k) summary PDF released by FDA; short quotation.",
          "snapshot": {
            "id": "maternal:fda-510k-summary-k170622-2026-10-15",
            "retrieved_at": "2026-10-15T13:53:06Z",
            "content_hash": "ccfae7e0450828be674e906e4315e58de9ea6430f2f8733463c262c71268329b",
            "source_effective_date": null,
            "public_archive_url": null,
            "source_state": "current"
          },
          "source": {
            "id": "maternal:openfda-k170622",
            "source_type": "regulator",
            "title": "FDA 510(k) premarket notification K170622: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (openFDA record)",
            "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170622",
            "identifiers": [
              {
                "scheme": "fda-510k",
                "value": "K170622",
                "normalized_value": "K170622",
                "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/pdf17/K170622.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-k170622.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",
            "replaced_by": null,
            "retirement_note": null
          }
        },
        {
          "evidence_role": "supports",
          "locator": "Predicate Device",
          "applicability_note": "510(k) summary PDF released by FDA; short quotation.",
          "snapshot": {
            "id": "maternal:fda-510k-summary-k170622-2026-10-15",
            "retrieved_at": "2026-10-15T13:53:06Z",
            "content_hash": "ccfae7e0450828be674e906e4315e58de9ea6430f2f8733463c262c71268329b",
            "source_effective_date": null,
            "public_archive_url": null,
            "source_state": "current"
          },
          "source": {
            "id": "maternal:openfda-k170622",
            "source_type": "regulator",
            "title": "FDA 510(k) premarket notification K170622: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (openFDA record)",
            "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170622",
            "identifiers": [
              {
                "scheme": "fda-510k",
                "value": "K170622",
                "normalized_value": "K170622",
                "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/pdf17/K170622.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-k170622.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",
            "replaced_by": null,
            "retirement_note": null
          }
        }
      ],
      "review": {
        "content_digest": "c0224bb1824fce661e12d9022bfbb2f75151975ab4666ace1083523bab36dc40",
        "current": [],
        "conflicting": [],
        "stale": [],
        "inactive": []
      },
      "api_path": "api/v1/claims/maternal--claim-fda-k170622-indication.json"
    }
  ],
  "decisions": [
    {
      "type": "regulatory_decision",
      "id": "maternal:regdec-fda-k170622",
      "product_id": "maternal:bakri-postpartum-balloon",
      "product_version": "Bakri Postpartum Balloon and Bakri Postpartum Balloon with Rapid Instillation Components as cleared under K170622 (special 510(k))",
      "indication": "Cleared intended use for each device, as the Indications for Use word it: \"intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted\".",
      "context_id": "maternal:ctx-fda-k170622-us",
      "jurisdictions": [
        "US"
      ],
      "jurisdiction_note": "United States",
      "authority_id": "core:fda",
      "decision_type": "clearance",
      "recall_class": null,
      "submission_id": "K170622",
      "pathway": "510k",
      "product_code": "OQY",
      "device_class": "II",
      "decision_date": "2017-03-31",
      "valid_to": null,
      "claim_id": "maternal:claim-fda-k170622-indication"
    }
  ],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "related_to",
        "label": "Balloon 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/bakri-postpartum-balloon/",
  "context_path": "api/v1/context/maternal--bakri-postpartum-balloon.md"
}