FDA Product Code PFJ: Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
Mechanical Dilation Of The Cervical Canal For Labor.
Leading manufacturers include Cook, Inc., Utah Medical Products, Inc. and TZ Medical.
3
Total
3
Cleared
173d
Avg days
2013
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times improving: avg
97d
recently vs 211d historically
FDA 510(k) Cleared Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor Devices (Product Code PFJ)
3 devices
Cleared
Oct 29, 2026
TZ Medical Birthing Balloon Kit
TZ Medical
Obstetrics & Gynecology
97d
Cleared
Aug 28, 2015
UTAH CVX-RIPE
Utah Medical Products, Inc.
Obstetrics & Gynecology
270d
Cleared
Sep 27, 2013
COOK CERVICAL RIPENING BALLOON
Cook, Inc.
Obstetrics & Gynecology
151d
About Product Code PFJ - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code PFJ since 2013, with 3 receiving FDA clearance (average review time: 173 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - PFJ Product Code
Recent submissions under PFJ have taken an average of 97 days to reach a decision - down from 211 days historically, suggesting improved FDA processing for this classification.
PFJ devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →