FDA product code HKI: Camera, Ophthalmic, Ac-Powered
HKI is the FDA product code for camera, ophthalmic, ac-powered. It is a Class II device, regulated under 21 CFR 886.1120 and reviewed by the Ophthalmic panel. FDA has cleared 157 510(k) submissions under HKI, 15 in the last five years, from 91 different applicants. The average 510(k) review took 123 days (median 103); 160 days on average over the last three years. FDA has posted 9 recalls for HKI devices.
Classification
| Field | Value |
|---|---|
| Device name | Camera, Ophthalmic, Ac-Powered |
| Device class | Class II |
| Regulation | 21 CFR 886.1120 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HKI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 184 |
| 2018 | 6 | 99 |
| 2019 | 4 | 84 |
| 2020 | 5 | 165 |
| 2021 | 4 | 144 |
| 2022 | 1 | 136 |
| 2023 | 5 | 236 |
| 2024 | 3 | 52 |
| 2025 | 4 | 164 |
| 2026 | 2 | 265 |
Compare with all 510(k) review times · Search every HKI clearance
Top HKI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kowa Co. , Ltd. | 12 | 2012-02-16 |
| Canon USA, Inc. | 12 | 2003-06-06 |
| Canon, Inc. | 7 | 2024-05-15 |
| Optomed OY | 5 | 2018-04-05 |
| Topcon Corp. | 5 | 2014-10-23 |
86 more applicants have HKI clearances. See the full list in Caduvo.
Most recent HKI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253176 | Beyond 700 Pty, Ltd. | TearView | 2026-06-22 | 269 |
| K251353 | Phelcom Technologies | Eyer 2 | 2026-01-16 | 261 |
| K252120 | Remidio Innovative Solutions Private Limited | Fundus On Phone Non Mydriatic (FOP NM-10) | 2025-12-12 | 158 |
| K250770 | Optina Diagnostics, Inc. | Optina-4C (MHRC-C1N) | 2025-09-04 | 175 |
| K243600 | Forus Health Pvt.Ltd | 3nethra neo HD FA; 3nethra neo HD | 2025-08-14 | 266 |
Recalls for HKI devices
9 product recalls in 9 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-12-20.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
Frequently asked questions
What is FDA product code HKI?
HKI is the FDA product code for camera, ophthalmic, ac-powered. It is a Class II device, regulated under 21 CFR 886.1120 and reviewed by the Ophthalmic panel.
What device class is HKI?
Class II, regulation 21 CFR 886.1120. Typical premarket route: 510(k).
How long does a 510(k) take for product code HKI?
Across 157 cleared submissions the average was 123 days from receipt to decision (median 103).
Which companies have the most HKI clearances?
Kowa Co. , Ltd. (12); Canon USA, Inc. (12); Canon, Inc. (7); Optomed OY (5); Topcon Corp. (5).
Have HKI devices been recalled?
Yes: 9 product recalls across 9 recall events; the most recent began 2018-12-20.
Next steps
- Run an FDA pathway report with predicate devices for product code HKI
- Run a recall and safety report across every HKI manufacturer
- Watch product code HKI 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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