FDA product code FFP: Dilator, Rectal
FFP is the FDA product code for dilator, rectal. It is a Class I device, regulated under 21 CFR 876.5450 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 5 510(k) submissions under FFP, from 5 different applicants. The average 510(k) review took 181 days (median 182).
Classification
| Field | Value |
|---|---|
| Device name | Dilator, Rectal |
| Device class | Class I |
| Regulation | 21 CFR 876.5450 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FFP clearance
Top FFP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mk Conquest Intl., Inc. | 1 | 1997-06-06 |
| Telemed Systems, Inc. | 1 | 1990-06-21 |
| Inamed Development Co. | 1 | 1990-01-18 |
| Primrose Medical, Inc. | 1 | 1989-09-29 |
| Cleveland Medical Supply & Services | 1 | 1983-05-27 |
Most recent FFP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K964634 | Mk Conquest Intl., Inc. | ANOKRYO | 1997-06-06 | 199 |
| K901426 | Telemed Systems, Inc. | COLONIC BALLOON DILATOR | 1990-06-21 | 87 |
| K894618 | Inamed Development Co. | INAMED RHEMO-D (TM) DILATOR | 1990-01-18 | 182 |
| K884713 | Primrose Medical, Inc. | COLONIC BALLOON DIALATORS | 1989-09-29 | 325 |
| K830354 | Cleveland Medical Supply & Services | COLORECTAL DILATOR | 1983-05-27 | 113 |
Recalls for FFP devices
openFDA lists no recalls for product code FFP.
Frequently asked questions
What is FDA product code FFP?
FFP is the FDA product code for dilator, rectal. It is a Class I device, regulated under 21 CFR 876.5450 and reviewed by the Gastroenterology and Urology panel.
What device class is FFP?
Class I, regulation 21 CFR 876.5450. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FFP?
Across 5 cleared submissions the average was 181 days from receipt to decision (median 182).
Which companies have the most FFP clearances?
Mk Conquest Intl., Inc. (1); Telemed Systems, Inc. (1); Inamed Development Co. (1); Primrose Medical, Inc. (1); Cleveland Medical Supply & Services (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FFP
- Run a recall and safety report across every FFP manufacturer
- Watch product code FFP 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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