{
  "release_id": "c7fb95f1d15a7d13",
  "id": "maternal:cook-cervical-ripening-balloon",
  "owner": "maternal",
  "kind": "product",
  "slug": "cook-cervical-ripening-balloon",
  "name": "Cook Cervical Ripening Balloon",
  "aliases": [
    "Cook cervical ripening balloon (K131206)"
  ],
  "atlases": [
    "maternal"
  ],
  "summary_plain": "A balloon catheter that dilates (opens) the cervix mechanically before labour is induced at term, when the cervix is not yet ready for induction. It is a mechanical option, not a medicine. In the United States the FDA cleared it in 2013 through the 510(k) route, which means FDA found it substantially equivalent to a device already on the market.",
  "summary_technical": "510(k) K131206, applicant Cook, Inc., decision Substantially Equivalent on 2013-09-27, traditional clearance, product code PFJ (openFDA name: Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor), regulation 884.4260, device class 2. The 510(k) summary (PDF fetched 2026-10-14, read from its OCR text) gives the intended use: \"indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction\". The clearance covers that use only. The product name in the plan is the openFDA device name.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-14",
  "last_evidence_check": "2026-10-14",
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "fda-product-code",
      "value": "PFJ",
      "normalized_value": "PFJ",
      "match": "broad",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "maternal": {
      "life-stage": [
        "childbirth"
      ],
      "care-area": [
        "labour-and-birth"
      ]
    }
  },
  "payload": {
    "subtype": "device",
    "model_or_formulation": "Cook Cervical Ripening Balloon, as named in the openFDA 510(k) record (K131206)",
    "version": "As cleared under K131206 on 2013-09-27",
    "intended_use_snapshots": [
      "maternal:openfda-510k-k131206-2026-10-14",
      "maternal:fda-510k-summary-k131206-2026-10-14"
    ]
  },
  "content_digest": "32955486a13b07f32928b5f125b0305350a0306fdb731a47c1784e7df6a89e81",
  "review": {
    "content_digest": "32955486a13b07f32928b5f125b0305350a0306fdb731a47c1784e7df6a89e81",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [
    {
      "release_id": "c7fb95f1d15a7d13",
      "id": "maternal:claim-fda-k131206",
      "owner": "maternal",
      "subject_entity_id": "maternal:cook-cervical-ripening-balloon",
      "category": "regulatory",
      "statement": "FDA cleared the Cook Cervical Ripening Balloon from applicant Cook, Inc. under 510(k) K131206, with the decision Substantially Equivalent dated 2013-09-27. The 510(k) summary states the intended use: \"indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction\". FDA classifies the product code, PFJ, as a catheter, balloon, for dilation of the cervical canal prior to labor, in device class 2.",
      "context": {
        "id": "maternal:ctx-fda-k131206-us",
        "label": "Cervical dilation before labour induction at term when the cervix is unfavorable, US 510(k) clearance of the Cook Cervical Ripening Balloon (K131206)",
        "recipient": "maternal",
        "population": "Women at term for whom labour induction is planned and whose cervix is unfavorable for induction. The cleared use is mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction (510(k) summary, Intended Use). It is not cleared for other times in pregnancy or for other uses.",
        "care_setting": "Not stated in the source",
        "geography": "United States (FDA clearance)",
        "life_stage_note": "Term pregnancy, before labour induction",
        "life_stage_terms": null,
        "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": [
            "Term pregnancy with a planned labour induction and an unfavorable cervix"
          ],
          "exclusion": [
            "Any other use or timing: the clearance covers only the stated intended use"
          ]
        }
      },
      "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. The summary is a scanned PDF read by OCR text; contraindications, warnings and performance data were not read. The openFDA record is the dataset copy as of its update date.",
      "editorial_state": "draft",
      "checked_at": "2026-10-14",
      "next_review_due": null,
      "valid_from": null,
      "valid_to": null,
      "citations": [
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            "source_effective_date": "2026-10-05",
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            "source_state": "current"
          },
          "source": {
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            "source_type": "regulator",
            "title": "FDA 510(k) premarket notification K131206: COOK CERVICAL RIPENING BALLOON (openFDA record)",
            "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K131206",
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            "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 on 2026-10-14 fetched the 510(k) summary PDF, whose text is read by OCR and which gives the intended use.",
            "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 mg-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mg-openfda-510k-k131206.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf13/K131206.pdf, fetched as mg-fda-510k-summary-k131206.pdf) is hash only; it is a scanned submission summary released by FDA, and the FDA website policies page (mg-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says FDA website content is not copyrighted unless noted. Only short quotations are used.",
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          "locator": "results[0].product_code and results[0].openfda.device_name",
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          "snapshot": {
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          "source": {
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            "source_type": "regulator",
            "title": "FDA 510(k) premarket notification K131206: COOK CERVICAL RIPENING BALLOON (openFDA record)",
            "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K131206",
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            "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 mg-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mg-openfda-510k-k131206.json. It includes a contact name and an address that FDA publishes; records here do not repeat them. The 510(k) summary PDF (https://www.accessdata.fda.gov/cdrh_docs/pdf13/K131206.pdf, fetched as mg-fda-510k-summary-k131206.pdf) is hash only; it is a scanned submission summary released by FDA, and the FDA website policies page (mg-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says FDA website content is not copyrighted unless noted. Only short quotations are used.",
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        {
          "evidence_role": "supports",
          "locator": "Section 6, Intended Use, and the Indications for Use statement",
          "applicability_note": "510(k) summary PDF released by FDA; short quotation.",
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            "content_hash": "68cd0727985854a0eac633b7535a51141231a4a82940f38fea112b4a5dc6f539",
            "source_effective_date": "2013-08-29",
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      "api_path": "api/v1/claims/maternal--claim-fda-k131206.json"
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  "decisions": [
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      "id": "maternal:regdec-fda-k131206",
      "product_id": "maternal:cook-cervical-ripening-balloon",
      "product_version": "Cook Cervical Ripening Balloon as cleared under K131206",
      "indication": "Cleared intended use, as the 510(k) summary words it: \"indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction\".",
      "context_id": "maternal:ctx-fda-k131206-us",
      "jurisdictions": [
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      "claim_id": "maternal:claim-fda-k131206"
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  "milestones": [],
  "relationships": {
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}