FME
5 FDA 510(k) clearances · Product code
56 daysmedian time to decision
79 days90th percentile
5clearances measured
FDA profile
- Official device name
- Gown, Examination
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6265
- Medical specialty
- General Hospital
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2000: 1 · 2001: 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 |
|---|---|---|
| KIMBERLY-CLARK PROFESSIONAL JACKET (K880385) | Kimberly-Clark Corp. | 1988-02-19 |
| MONITOR/VITAL SIGNS TRAY (K811915) | American Hospital Supply Corp. | 1981-07-28 |
| EXAM GOWN (K770476) | General Medical Co. | 1977-05-06 |
| CROWNTEX EXAM. CAPE & GOWN (K760954) | Graham Manufacturing Co. | 1976-12-30 |
| SHIRT, MITTEN CUFF INFANT (K760360) | Precept, Inc. | 1976-10-20 |
Track FME automatically
Every clearance here is in the API, with alerts when new ones post.