HKL
6 FDA 510(k) clearances · Product code
61 daysmedian time to decision
149 days90th percentile
6clearances measured
FDA profile
- Official device name
- Retinoscope, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1780
- Medical specialty
- Ophthalmic
Download CSV table Client report (share link) ◉ Watch
Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.
Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.
| Record | Firm | Date | Builder |
|---|---|---|---|
| PANORET, MODEL 1000A (K001111) | Cmt Medical Technologies, Ltd. | 2000-07-07 | + Add |
| STREAK RETINOSCOPE RX-1 (K950789) | Neitz Instruments Company, Ltd. | 1995-03-28 | + Add |
| STREAK RETINOSCOPE RX-2 (K950790) | Neitz Instruments Company, Ltd. | 1995-03-22 | + Add |
| VISTA STREAK RETINOSCOPE (AC-POWERED) (K893171) | Keeler Instruments, Inc. | 1989-09-21 | + Add |
| KOI BLUE FIELD ENTOPTOSCOPE (K812764) | Koi, Inc. | 1981-12-02 | + Add |
| MOIRE FRINGE VISOMETER AFTER LOTMAR (K800238) | Hagg-Streit Service, Inc. | 1980-03-10 | + Add |
Track HKL automatically
Every clearance here is in the API, with alerts when new ones post.