FDA product code HKX: Tonometer, Ac-Powered
HKX is the FDA product code for tonometer, ac-powered. It is a Class II device, regulated under 21 CFR 886.1930 and reviewed by the Ophthalmic panel. FDA has cleared 58 510(k) submissions under HKX, 2 in the last five years, from 45 different applicants. The average 510(k) review took 146 days (median 102); 46 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Tonometer, Ac-Powered |
| Device class | Class II |
| Regulation | 21 CFR 886.1930 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
510(k) clearances per year for HKX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 272 |
| 2018 | 1 | 260 |
| 2019 | 3 | 326 |
| 2023 | 1 | 329 |
| 2025 | 1 | 46 |
Compare with all 510(k) review times · Search every HKX clearance
Top HKX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Keeler Instruments, Inc. | 5 | 2019-02-08 |
| Bio-Rad | 5 | 1993-06-22 |
| Luneau Sas | 2 | 2017-04-24 |
| Reichert, Inc. | 2 | 2008-08-07 |
| Nidek, Inc. | 2 | 2003-12-04 |
40 more applicants have HKX clearances. See the full list in Caduvo.
Most recent HKX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253039 | Topcon Corporation | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | 2025-11-07 | 46 |
| K223739 | Medimaging Integrated Solution, Inc. | VS Tabletop Tonometer | 2023-11-08 | 329 |
| K190382 | Company Elamed | Intraocular Pressure Tonometer EASYTON | 2019-12-06 | 290 |
| K181260 | Medimaging Integrated Solution, Inc (Miis) | MiiS Horus Scope DPT 100 | 2019-06-21 | 406 |
| K181143 | Keeler Instruments, Inc. | Keeler TonoCare Tonometer | 2019-02-08 | 283 |
Recalls for HKX devices
openFDA lists no recalls for product code HKX.
Frequently asked questions
What is FDA product code HKX?
HKX is the FDA product code for tonometer, ac-powered. It is a Class II device, regulated under 21 CFR 886.1930 and reviewed by the Ophthalmic panel.
What device class is HKX?
Class II, regulation 21 CFR 886.1930. Typical premarket route: 510(k).
How long does a 510(k) take for product code HKX?
Across 58 cleared submissions the average was 146 days from receipt to decision (median 102).
Which companies have the most HKX clearances?
Keeler Instruments, Inc. (5); Bio-Rad (5); Luneau Sas (2); Reichert, Inc. (2); Nidek, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code HKX
- Run a recall and safety report across every HKX manufacturer
- Watch product code HKX 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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