FDA product code FNW: Pad, Kelly
FNW is the FDA product code for pad, kelly. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under FNW, from 2 different applicants. The average 510(k) review took 242 days (median 242).
Classification
| Field | Value |
|---|---|
| Device name | Pad, Kelly |
| Device class | Class II |
| Regulation | 21 CFR 878.4370 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FNW clearance
Top FNW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pmt, Inc. | 1 | 1984-05-30 |
| Reagent Laboratory, Inc. | 1 | 1984-05-21 |
Most recent FNW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K831117 | Pmt, Inc. | MICROMAT W/VARIOUS MODELS | 1984-05-30 | 421 |
| K841183 | Reagent Laboratory, Inc. | SODIUM CHLORIDE SOLUTION BLOOD CELL | 1984-05-21 | 62 |
Recalls for FNW devices
openFDA lists no recalls for product code FNW.
Frequently asked questions
What is FDA product code FNW?
FNW is the FDA product code for pad, kelly. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General and Plastic Surgery panel.
What device class is FNW?
Class II, regulation 21 CFR 878.4370. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FNW?
Across 2 cleared submissions the average was 242 days from receipt to decision (median 242).
Which companies have the most FNW clearances?
Pmt, Inc. (1); Reagent Laboratory, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FNW
- Run a recall and safety report across every FNW manufacturer
- Watch product code FNW 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.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times