# K143424: Utah CVX-Ripe

- Pathway: 510(k) (Traditional)
- Applicant: Utah Medical Products, Inc.
- Decided: Aug 28, 2015 after 270 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: 3 generations back to K021012 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131206: Cook Cervical Ripening Balloon, Cook, Inc. (2013) Summary page 4.

## Indications for use
The UTAH CVX-RIPE™ is intended to mechanically improve the favorability of the cervix of pregnant patients at term gestation, in which induction of labor is medically indicated.

Source page: https://510kreport.com/device/K143424
Methodology: https://510kreport.com/methodology