FDA product code FIW: Alarm, Pillow Pressure
FIW is the FDA product code for alarm, pillow pressure. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under FIW. The average 510(k) review took 30 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Alarm, Pillow Pressure |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every FIW clearance
Top FIW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cordis Corp. | 1 | 1978-01-26 |
Most recent FIW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K772355 | Cordis Corp. | BLOOD LINE COMP. NEG. PRESS. PILLOW | 1978-01-26 | 30 |
Recalls for FIW devices
openFDA lists no recalls for product code FIW.
Frequently asked questions
What is FDA product code FIW?
FIW is the FDA product code for alarm, pillow pressure. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FIW?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FIW?
Across 1 cleared submissions the average was 30 days from receipt to decision (median 30).
Which companies have the most FIW clearances?
Cordis Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FIW
- Run a recall and safety report across every FIW manufacturer
- Watch product code FIW 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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