FSD
5 FDA 510(k) clearances · Product code
30 daysmedian time to decision
120 days90th percentile
5clearances measured
FDA profile
- Official device name
- Binder, Abdominal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5160
- Medical specialty
- General Hospital
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2000: 2 · 2002: 12 · 2013: 13 · 2014: 14 · 2023: 15
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 |
|---|---|---|
| THE POUCH GROIN & ABDOMINAL STRESS AID (K892379) | Kuhn Industries | 1989-07-20 |
| DOCE ALL-IN-THE-EAR AID (K822817) | Fidelty Hearing Instruments, Inc. | 1983-01-18 |
| EARETTE HEARING AID SEARS #8054 (K810379) | Oticon Corp. | 1981-03-04 |
| MATERNITY SUPPORTER (K770162) | R.G. Moore | 1977-02-09 |
| DISPOSABLE ABDOMINAL BINDER (K760772) | Tecnol New Jersey Wound Care, Inc. | 1976-11-03 |
Track FSD automatically
Every clearance here is in the API, with alerts when new ones post.