FDA product code PBP: Rectal Insert
PBP is the FDA product code for rectal insert. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under PBP, 1 in the last five years, from 2 different applicants. The average 510(k) review took 187 days (median 187); 265 days on average over the last three years.
Definition
Acts as a barrier to the passage of fecal matter through the rectum.
Classification
| Field | Value |
|---|---|
| Device name | Rectal Insert |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PBP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 265 |
Compare with all 510(k) review times · Search every PBP clearance
Top PBP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Minnesota Medical Technologies | 1 | 2025-07-22 |
| Renew Medical, Inc. | 1 | 2012-10-26 |
Most recent PBP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243367 | Minnesota Medical Technologies | Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) | 2025-07-22 | 265 |
| K122003 | Renew Medical, Inc. | RENEW INSERT | 2012-10-26 | 109 |
Recalls for PBP devices
openFDA lists no recalls for product code PBP.
Frequently asked questions
What is FDA product code PBP?
PBP is the FDA product code for rectal insert. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel.
What device class is PBP?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k).
How long does a 510(k) take for product code PBP?
Across 2 cleared submissions the average was 187 days from receipt to decision (median 187).
Which companies have the most PBP clearances?
Minnesota Medical Technologies (1); Renew Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PBP
- Run a recall and safety report across every PBP manufacturer
- Watch product code PBP 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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