FDA product code FFH: Collector, Urine, Pediatric, For Indwelling Catheter
FFH is the FDA product code for collector, urine, pediatric, for indwelling catheter. It is a Class II device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under FFH, from 3 different applicants. The average 510(k) review took 71 days (median 75).
Classification
| Field | Value |
|---|---|
| Device name | Collector, Urine, Pediatric, For Indwelling Catheter |
| Device class | Class II |
| Regulation | 21 CFR 876.5250 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FFH clearance
Top FFH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Davol, Inc. | 1 | 1990-12-20 |
| Laytech Medical Co. | 1 | 1990-01-31 |
| Mercury Enterprises, Inc. | 1 | 1987-08-10 |
Most recent FFH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K905016 | Davol, Inc. | PEDIATRIC AND INFANT CATH KITS | 1990-12-20 | 43 |
| K896581 | Laytech Medical Co. | PEDIATRIC DRAIN BAG | 1990-01-31 | 75 |
| K871789 | Mercury Enterprises, Inc. | INTECARE PEDIATRIC URINE COLLECTOR | 1987-08-10 | 96 |
Recalls for FFH devices
openFDA lists no recalls for product code FFH.
Frequently asked questions
What is FDA product code FFH?
FFH is the FDA product code for collector, urine, pediatric, for indwelling catheter. It is a Class II device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel.
What device class is FFH?
Class II, regulation 21 CFR 876.5250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FFH?
Across 3 cleared submissions the average was 71 days from receipt to decision (median 75).
Which companies have the most FFH clearances?
Davol, Inc. (1); Laytech Medical Co. (1); Mercury Enterprises, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FFH
- Run a recall and safety report across every FFH manufacturer
- Watch product code FFH 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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