FDA product code PFJ: Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
PFJ is the FDA product code for catheter, balloon, dilation of cervical canal prior to labor. It is a Class II device, regulated under 21 CFR 884.4260 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 2 510(k) submissions under PFJ, from 2 different applicants. The average 510(k) review took 210 days (median 210). FDA has posted 1 recall for PFJ devices.
Definition
Mechanical dilation of the cervical canal for labor.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor |
| Device class | Class II |
| Regulation | 21 CFR 884.4260 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every PFJ clearance
Top PFJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Utah Medical Products, Inc. | 1 | 2015-08-28 |
| Cook, Inc. | 1 | 2013-09-27 |
Most recent PFJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K143424 | Utah Medical Products, Inc. | UTAH CVX-RIPE | 2015-08-28 | 270 |
| K131206 | Cook, Inc. | COOK CERVICAL RIPENING BALLOON | 2013-09-27 | 151 |
Recalls for PFJ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-12-03.
Frequently asked questions
What is FDA product code PFJ?
PFJ is the FDA product code for catheter, balloon, dilation of cervical canal prior to labor. It is a Class II device, regulated under 21 CFR 884.4260 and reviewed by the Obstetrics and Gynecology panel.
What device class is PFJ?
Class II, regulation 21 CFR 884.4260. Typical premarket route: 510(k).
How long does a 510(k) take for product code PFJ?
Across 2 cleared submissions the average was 210 days from receipt to decision (median 210).
Which companies have the most PFJ clearances?
Utah Medical Products, Inc. (1); Cook, Inc. (1).
Have PFJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code PFJ
- Run a recall and safety report across every PFJ manufacturer
- Watch product code PFJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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