Cook Cervical Ripening Balloon

Context 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

Term pregnancy, before labour induction

Gestational age

Not reported

Postnatal age

Not reported

Follow-up

Not applicable (regulatory context)

• Regulatory Evidence stage not applicable Certainty not assessed

  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.

  Applies to Maternal

  • 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.
  • Not stated in the source
  • United States (FDA clearance)
  • Term pregnancy, before labour induction
  • Gestational age Not reported
  • Postnatal age Not reported

  Follow-up Not applicable (regulatory context)

  Certainty method

  Not assessed

  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.

  Last checked

  2026-10-14

  Next evidence check due

  Not scheduled

  Sources and citations (3)

  1. Supports FDA 510(k) premarket notification K131206: COOK CERVICAL RIPENING BALLOON (openFDA record)

     Regulator · 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. · 510(k): K131206

     Locator

     results[0].decision_date and results[0].decision_description

     How it applies

     openFDA 510(k) JSON, CC0.

     Retrieved

     2026-10-14T18:18:25Z

     Source effective date

     2026-10-05

     Source state

     Current

     Snapshot hash

     dd47815eb3831628bdaf22093e3b979cb958887ed15d4767a912973401a4cb82

     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.

  2. Supports FDA 510(k) premarket notification K131206: COOK CERVICAL RIPENING BALLOON (openFDA record)

     Regulator · 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. · 510(k): K131206

     Locator

     results[0].product_code and results[0].openfda.device_name

     How it applies

     openFDA 510(k) JSON, CC0.

     Retrieved

     2026-10-14T18:18:25Z

     Source effective date

     2026-10-05

     Source state

     Current

     Snapshot hash

     dd47815eb3831628bdaf22093e3b979cb958887ed15d4767a912973401a4cb82

     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.

  3. Supports FDA 510(k) premarket notification K131206: COOK CERVICAL RIPENING BALLOON (openFDA record)

     Regulator · 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. · 510(k): K131206

     Locator

     Section 6, Intended Use, and the Indications for Use statement

     How it applies

     510(k) summary PDF released by FDA; short quotation.

     Retrieved

     2026-10-14T19:15:14Z

     Source effective date

     2013-08-29

     Source state

     Current

     Snapshot hash

     68cd0727985854a0eac633b7535a51141231a4a82940f38fea112b4a5dc6f539

     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.