FDA product code FFD: Evacuator, Bladder, Manually Operated
FFD is the FDA product code for evacuator, bladder, manually operated. It is a Class I device, regulated under 21 CFR 876.4370 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under FFD, from 2 different applicants. The average 510(k) review took 22 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Evacuator, Bladder, Manually Operated |
| Device class | Class I |
| Regulation | 21 CFR 876.4370 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FFD clearance
Top FFD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cumes-Honikman Partnership | 1 | 1987-12-03 |
| V. Mueller O.V. Baxter Healthcare Corp. | 1 | 1976-10-15 |
Most recent FFD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K874410 | Cumes-Honikman Partnership | CUMEVAC | 1987-12-03 | 36 |
| K760793 | V. Mueller O.V. Baxter Healthcare Corp. | ADAPTER FOR ELLIK EVACUATOR | 1976-10-15 | 8 |
Recalls for FFD devices
openFDA lists no recalls for product code FFD.
Frequently asked questions
What is FDA product code FFD?
FFD is the FDA product code for evacuator, bladder, manually operated. It is a Class I device, regulated under 21 CFR 876.4370 and reviewed by the Gastroenterology and Urology panel.
What device class is FFD?
Class I, regulation 21 CFR 876.4370. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FFD?
Across 2 cleared submissions the average was 22 days from receipt to decision (median 22).
Which companies have the most FFD clearances?
Cumes-Honikman Partnership (1); V. Mueller O.V. Baxter Healthcare Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FFD
- Run a recall and safety report across every FFD manufacturer
- Watch product code FFD 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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