# Cook Cervical Ripening Balloon Product · id `maternal:cook-cervical-ripening-balloon` · Maternal & Newborn Atlas · release `c7fb95f1d15a7d13` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Also called: Cook cervical ripening balloon (K131206) Browse, life stage: Childbirth Browse, care area: Labour and birth ## In plain language 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. ## Technical summary 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. ## Claims, with the population each applies to ## 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) ### 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. - Category: Regulatory - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: 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) - 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 - Sources: 1. Supports: FDA 510(k) premarket notification K131206: COOK CERVICAL RIPENING BALLOON (openFDA record) (Regulator, 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.) Locator: results\[0\].decision\_date and results\[0\].decision\_description. Retrieved 2026-10-14T18:18:25Z. Source state: Current. Snapshot hash: dd47815eb3831628bdaf22093e3b979cb958887ed15d4767a912973401a4cb82. How it applies: openFDA 510(k) JSON, CC0. 2. Supports: FDA 510(k) premarket notification K131206: COOK CERVICAL RIPENING BALLOON (openFDA record) (Regulator, 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.) Locator: results\[0\].product\_code and results\[0\].openfda.device\_name. Retrieved 2026-10-14T18:18:25Z. Source state: Current. Snapshot hash: dd47815eb3831628bdaf22093e3b979cb958887ed15d4767a912973401a4cb82. How it applies: openFDA 510(k) JSON, CC0. 3. Supports: FDA 510(k) premarket notification K131206: COOK CERVICAL RIPENING BALLOON (openFDA record) (Regulator, 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.) Locator: Section 6, Intended Use, and the Indications for Use statement. Retrieved 2026-10-14T19:15:14Z. Source state: Current. Snapshot hash: 68cd0727985854a0eac633b7535a51141231a4a82940f38fea112b4a5dc6f539. How it applies: 510(k) summary PDF released by FDA; short quotation. ## Guidance, authorization and access ### Regulatory decision `maternal:regdec-fda-k131206` - Product: Cook Cervical Ripening Balloon (`maternal:cook-cervical-ripening-balloon`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Clearance, 2013-09-27 - Product version: Cook Cervical Ripening Balloon as cleared under K131206 - Pathway: 510(k) - Submission: K131206 - Product code: PFJ - Device class: II - 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". - Jurisdictions: United States; note: United States - Applies to: 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) - Basis: claim `maternal:claim-fda-k131206` ## Connected pages - Mechanical cervical ripening: Induction of labour (`maternal:induction-of-labour`) - Filed under this front: Procedures and birth care (`maternal:front-procedures-and-birth-care`) ## Provenance Content hash: 32955486a13b07f32928b5f125b0305350a0306fdb731a47c1784e7df6a89e81 Last substantive edit: 2026-10-14 Evidence last checked: 2026-10-14