HLR
7 FDA 510(k) clearances · Product code
33 daysmedian time to decision
108 days90th percentile
7clearances measured
FDA profile
- Official device name
- Keratoscope, Battery-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1350
- Medical specialty
- Ophthalmic
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SURG-K SURGICAL KERATOMETER (K901553) | The Sanborn Co. | 1990-07-20 |
| QRK 100, QUALITATIVE RING KERATOSCOPE (K882902) | Technitex, Inc. | 1988-08-04 |
| JEDMED/POLACK KERATOSCOPE HS/SL (K882618) | Gamut Ent. | 1988-07-13 |
| REUSABLE SURGICAL KERATOSCOPE (K864639) | Jedmed Instrument Co. | 1986-12-29 |
| PLACIDO DISC (K854054) | Cutler Medical Instruments | 1985-12-27 |
| KARICKHOFF KERATOSCOPE (K830008) | Surgidev Corp. | 1983-01-26 |
| HAND KERATOSCOPE (K821080) | Medical Equipment Designs, Inc. | 1982-05-24 |
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Every clearance here is in the API, with alerts when new ones post.