FDA product code HKL: Retinoscope, Ac-Powered
HKL is the FDA product code for retinoscope, ac-powered. It is a Class II device, regulated under 21 CFR 886.1780 and reviewed by the Ophthalmic panel. FDA has cleared 6 510(k) submissions under HKL, from 5 different applicants. The average 510(k) review took 67 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Retinoscope, Ac-Powered |
| Device class | Class II |
| Regulation | 21 CFR 886.1780 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HKL clearance
Top HKL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Neitz Instruments Company, Ltd. | 2 | 1995-03-28 |
| Cmt Medical Technologies, Ltd. | 1 | 2000-07-07 |
| Keeler Instruments, Inc. | 1 | 1989-09-21 |
| Koi, Inc. | 1 | 1981-12-02 |
| Hagg-Streit Service, Inc. | 1 | 1980-03-10 |
Most recent HKL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K001111 | Cmt Medical Technologies, Ltd. | PANORET, MODEL 1000A | 2000-07-07 | 92 |
| K950789 | Neitz Instruments Company, Ltd. | STREAK RETINOSCOPE RX-1 | 1995-03-28 | 35 |
| K950790 | Neitz Instruments Company, Ltd. | STREAK RETINOSCOPE RX-2 | 1995-03-22 | 29 |
| K893171 | Keeler Instruments, Inc. | VISTA STREAK RETINOSCOPE (AC-POWERED) | 1989-09-21 | 149 |
| K812764 | Koi, Inc. | KOI BLUE FIELD ENTOPTOSCOPE | 1981-12-02 | 61 |
Recalls for HKL devices
openFDA lists no recalls for product code HKL.
Frequently asked questions
What is FDA product code HKL?
HKL is the FDA product code for retinoscope, ac-powered. It is a Class II device, regulated under 21 CFR 886.1780 and reviewed by the Ophthalmic panel.
What device class is HKL?
Class II, regulation 21 CFR 886.1780. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HKL?
Across 6 cleared submissions the average was 67 days from receipt to decision (median 48).
Which companies have the most HKL clearances?
Neitz Instruments Company, Ltd. (2); Cmt Medical Technologies, Ltd. (1); Keeler Instruments, Inc. (1); Koi, Inc. (1); Hagg-Streit Service, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HKL
- Run a recall and safety report across every HKL manufacturer
- Watch product code HKL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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