HKM
7 FDA 510(k) clearances · Product code
35 daysmedian time to decision
139 days90th percentile
7clearances measured
FDA profile
- Official device name
- Retinoscope, Battery-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1780
- Medical specialty
- Ophthalmic
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT (K964338) | Rudolf Riester GmbH & Co. KG | 1997-01-09 |
| STREAK RETINOSCOPE RX-3 (K950791) | Neitz Instruments Company, Ltd. | 1995-03-28 |
| STREAK RETINOSCOPE RX-RP (K950795) | Neitz Instruments Company, Ltd. | 1995-03-28 |
| SPOT RETINOSCOPE RX-3SP (K950793) | Neitz Instruments Company, Ltd. | 1995-03-28 |
| STREAK RETINOSCOPE RX-RC (K950794) | Neitz Instruments Company, Ltd. | 1995-03-28 |
| STREAK RETINOSCOPE RX-3A (K950792) | Neitz Instruments Company, Ltd. | 1995-03-28 |
| GENERATED RETINAL REFLEX IMAGERY SYS (K840840) | Electro Optical Instruments | 1984-07-12 |
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Every clearance here is in the API, with alerts when new ones post.