HKY
- Product code
- HKY
- Device name
- Tonometer, Manual
- Device class
- Class 2
- 21 CFR
- 21 CFR 886.1930
- Medical specialty
- Ophthalmic
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 56
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K241447 | 2024-09-27 | Icare Finland OY | iCare ST500 (TA04) | |
| K233516 | 2024-05-01 | Reichert, Inc. | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes ( | |
| K234037 | 2024-02-09 | Cats Tonometer, LLC | CATS-L Tonometer Prism | |
| K232143 | 2023-10-23 | Huvitz Co., Ltd. | Applanation Tonometer HT-5000 |
Official FDA classification page: HKY
Classification and pathway per current FDA publications. Data from openFDA (CC0).