# K131206: Cook Cervical Ripening Balloon

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Sep 27, 2013 after 151 days
- Product code: PFJ (Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor)
- Device class: 2
- Regulation: 21 CFR 884.4260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K021012 (2002). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040625: Atad Ard Catheter, Atad Developments, Ltd. (2005) Summary page 1.

## Most influential descendants
- K160664: Aqueduct 100 Cervical Dilator (2016), 3 descendants of its own
- K202433: Aqueduct 200 Cervical Dilation Balloon Catheter (2021), 0 descendants of its own
- K202427: Aqueduct 100 Plus Cervical Dilation Balloon Catheter (2020), 0 descendants of its own
- K190813: CrossBay Cervical Dilator Catheter System (2019), 0 descendants of its own
- K143424: Utah CVX-Ripe (2015), 0 descendants of its own

## Indications for use
The Cook Cervical Ripening Balloon is indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction.

Source page: https://510kreport.com/device/K131206
Methodology: https://510kreport.com/methodology