FZF
7 FDA 510(k) clearances · Product code
49 daysmedian time to decision
103 days90th percentile
7clearances measured
FDA profile
- Official device name
- Splint, Extremity, Inflatable, External
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.3900
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1997: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| COMPRESAID (K881516) | R. Evans Corp. | 1988-04-29 |
| INFLATABLE FULL LEG SPLINT (K874051) | Vinyl Technology, Inc. | 1987-11-23 |
| INFLATABLE FOOT & ANKLE SPLINT (K874050) | Vinyl Technology, Inc. | 1987-11-23 |
| INFLATABLE HALF LEG SPLINT (K874052) | Vinyl Technology, Inc. | 1987-11-23 |
| INFLATABLE FULL ARM SPLINT (K874053) | Vinyl Technology, Inc. | 1987-11-23 |
| INFLATABLE AIR SPLINTS (K853600) | Hospitak, Inc. | 1985-09-19 |
| URIAS PRESSURE SPLINTS, & FIRST AID (K831764) | Svenol Andersen | 1983-09-12 |
Track FZF automatically
Every clearance here is in the API, with alerts when new ones post.