HPA
5 FDA 510(k) clearances · Product code
49 daysmedian time to decision
161 days90th percentile
5clearances measured
FDA profile
- Official device name
- Frame, Trial, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1415
- Medical specialty
- Ophthalmic
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1993: 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 |
|---|---|---|
| ATL 225 MW TRAIL LENS SET (K852548) | Ascon Medical Instruments, Ltd. | 1985-07-31 |
| ATF 101 TRAIL FRAME (K852126) | Ascon Medical Instruments, Ltd. | 1985-06-05 |
| WOODLYN LIGHTWEIGHT TRIAL FRAME (K841768) | Woodlyn, Inc. | 1984-06-01 |
| IMAGE DEFLECTOR (K833669) | Michael Onufryk | 1984-03-27 |
| UNIVERSAL TRIAL FRAMEE (K821084) | Medical Equipment Designs, Inc. | 1982-06-14 |
Track HPA automatically
Every clearance here is in the API, with alerts when new ones post.