FQP
5 FDA 510(k) clearances · Product code
63 daysmedian time to decision
77 days90th percentile
5clearances measured
FDA profile
- Official device name
- Lamp, Operating-Room
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2012: 23 · 2013: 13 · 2014: 6 · 2018: 18 · 2020: 19 · 2025: 19
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 |
|---|---|---|
| ACULUX, MODEL AX3001, AX3002 (K001223) | Aculux | 2000-06-23 |
| SYNTHES LIGHT GUIDE (K993314) | Synthes (Usa) | 1999-12-06 |
| SURGICAL LIGHT 22 SERIES (K781581) | American Sterilizer Co. | 1978-10-17 |
| HANDLES, LIGHT, SURGICAL, STEOILE (K770812) | Sybron Corp. | 1977-05-23 |
| SURGICAL LIGHT - CHALLENGE 22 SERIES (K761018) | Amsco Co. | 1977-01-26 |
Track FQP automatically
Every clearance here is in the API, with alerts when new ones post.