HPQ
5 FDA 510(k) clearances · Product code
104 daysmedian time to decision
107 days90th percentile
5clearances measured
FDA profile
- Official device name
- Headlamp, Operating, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4335
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 1996: 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 |
|---|---|---|
| WELCH ALLYN FIBER OPTIC HEADLIGNT (K952289) | Welch Allyn, Inc. | 1995-07-14 |
| FIBER HEAD LIGHT FH-300 (K951337) | Neitz Instruments Company, Ltd. | 1995-06-08 |
| KEELER FIBEROPTIC HEADLAMP (K861747) | Keeler Instruments, Inc. | 1986-08-21 |
| KEELER DUAL LIGHTSOURCE (K861746) | Keeler Instruments, Inc. | 1986-08-21 |
| HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS (K822272) | Kelleher Corp. | 1982-11-10 |
Track HPQ automatically
Every clearance here is in the API, with alerts when new ones post.