FDA product code HKM: Retinoscope, Battery-Powered
HKM is the FDA product code for retinoscope, battery-powered. It is a Class I device, regulated under 21 CFR 886.1780 and reviewed by the Ophthalmic panel. FDA has cleared 7 510(k) submissions under HKM, from 3 different applicants. The average 510(k) review took 55 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Retinoscope, Battery-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.1780 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HKM clearance
Top HKM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Neitz Instruments Company, Ltd. | 5 | 1995-03-28 |
| Rudolf Riester GmbH & Co. KG | 1 | 1997-01-09 |
| Electro Optical Instruments | 1 | 1984-07-12 |
Most recent HKM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K964338 | Rudolf Riester GmbH & Co. KG | RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT | 1997-01-09 | 70 |
| K950793 | Neitz Instruments Company, Ltd. | SPOT RETINOSCOPE RX-3SP | 1995-03-28 | 35 |
| K950795 | Neitz Instruments Company, Ltd. | STREAK RETINOSCOPE RX-RP | 1995-03-28 | 35 |
| K950791 | Neitz Instruments Company, Ltd. | STREAK RETINOSCOPE RX-3 | 1995-03-28 | 35 |
| K950792 | Neitz Instruments Company, Ltd. | STREAK RETINOSCOPE RX-3A | 1995-03-28 | 35 |
Recalls for HKM devices
openFDA lists no recalls for product code HKM.
Frequently asked questions
What is FDA product code HKM?
HKM is the FDA product code for retinoscope, battery-powered. It is a Class I device, regulated under 21 CFR 886.1780 and reviewed by the Ophthalmic panel.
What device class is HKM?
Class I, regulation 21 CFR 886.1780. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HKM?
Across 7 cleared submissions the average was 55 days from receipt to decision (median 35).
Which companies have the most HKM clearances?
Neitz Instruments Company, Ltd. (5); Rudolf Riester GmbH & Co. KG (1); Electro Optical Instruments (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HKM
- Run a recall and safety report across every HKM manufacturer
- Watch product code HKM 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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