FDA product code HKY: Tonometer, Manual
HKY is the FDA product code for tonometer, manual. It is a Class II device, regulated under 21 CFR 886.1930 and reviewed by the Ophthalmic panel. FDA has cleared 56 510(k) submissions under HKY, 6 in the last five years, from 42 different applicants. The average 510(k) review took 134 days (median 94); 120 days on average over the last three years. FDA has posted 2 recalls for HKY devices.
Classification
| Field | Value |
|---|---|
| Device name | Tonometer, Manual |
| Device class | Class II |
| Regulation | 21 CFR 886.1930 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HKY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 74 |
| 2018 | 3 | 79 |
| 2019 | 1 | 218 |
| 2020 | 2 | 181 |
| 2021 | 1 | 165 |
| 2022 | 2 | 232 |
| 2023 | 1 | 96 |
| 2024 | 3 | 120 |
Compare with all 510(k) review times · Search every HKY clearance
Top HKY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Icare Finland OY | 7 | 2024-09-27 |
| Cats Tonometer, LLC | 3 | 2024-02-09 |
| Reichert, Inc. | 2 | 2024-05-01 |
| Takagi Seiko Co., Ltd. | 2 | 2018-12-10 |
| Falck Medical, Inc. | 2 | 2016-01-15 |
37 more applicants have HKY clearances. See the full list in Caduvo.
Most recent HKY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241447 | Icare Finland OY | iCare ST500 (TA04) | 2024-09-27 | 128 |
| K233516 | Reichert, Inc. | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) | 2024-05-01 | 182 |
| K234037 | Cats Tonometer, LLC | CATS-L Tonometer Prism | 2024-02-09 | 50 |
| K232143 | Huvitz Co., Ltd. | Applanation Tonometer HT-5000 | 2023-10-23 | 96 |
| K220852 | Icare Finland OY | iCare IC200 | 2022-10-06 | 197 |
Recalls for HKY devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-09-08.
Frequently asked questions
What is FDA product code HKY?
HKY is the FDA product code for tonometer, manual. It is a Class II device, regulated under 21 CFR 886.1930 and reviewed by the Ophthalmic panel.
What device class is HKY?
Class II, regulation 21 CFR 886.1930. Typical premarket route: 510(k).
How long does a 510(k) take for product code HKY?
Across 56 cleared submissions the average was 134 days from receipt to decision (median 94).
Which companies have the most HKY clearances?
Icare Finland OY (7); Cats Tonometer, LLC (3); Reichert, Inc. (2); Takagi Seiko Co., Ltd. (2); Falck Medical, Inc. (2).
Have HKY devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2014-09-08.
Next steps
- Run an FDA pathway report with predicate devices for product code HKY
- Run a recall and safety report across every HKY manufacturer
- Watch product code HKY 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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