FDA product code HKO: Refractometer, Ophthalmic
HKO is the FDA product code for refractometer, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1760 and reviewed by the Ophthalmic panel. FDA has cleared 35 510(k) submissions under HKO, from 19 different applicants. The average 510(k) review took 95 days (median 75). FDA has posted 5 recalls for HKO devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Refractometer, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.1760 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HKO clearance
Top HKO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nidek, Inc. | 8 | 1990-07-27 |
| Canon USA, Inc. | 4 | 1994-02-17 |
| Stereo Optical Co., Inc. | 3 | 1993-04-06 |
| American Optical Corp. | 3 | 1981-08-18 |
| R.H. Burton Co. | 2 | 1993-04-05 |
14 more applicants have HKO clearances. See the full list in Caduvo.
Most recent HKO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K031831 | Topcon Medical Systems, Inc. | TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM | 2003-12-19 | 189 |
| K000327 | Visx, Incorporated | WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 | 2000-05-02 | 90 |
| K951179 | Kudi Kalu, Inc. | DIGITAL RETINOSCOPIC PHOTOMETER | 1995-05-30 | 75 |
| K945959 | Tomey Corporation USA | VIDEO VISION ANALYZER (VIVA), VRB 100 | 1995-03-01 | 84 |
| K942242 | Cannon U.S.A., Inc. | AUTO REF-KERATOMETER, RK-3 | 1994-09-02 | 116 |
Recalls for HKO devices
5 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-02-18.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2020 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code HKO?
HKO is the FDA product code for refractometer, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1760 and reviewed by the Ophthalmic panel.
What device class is HKO?
Class I, regulation 21 CFR 886.1760. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HKO?
Across 35 cleared submissions the average was 95 days from receipt to decision (median 75).
Which companies have the most HKO clearances?
Nidek, Inc. (8); Canon USA, Inc. (4); Stereo Optical Co., Inc. (3); American Optical Corp. (3); R.H. Burton Co. (2).
Have HKO devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2026-02-18.
Next steps
- Run an FDA pathway report with predicate devices for product code HKO
- Run a recall and safety report across every HKO manufacturer
- Watch product code HKO 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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