HKY — Tonometer, Manual Class II
FDA product code HKY covers "Tonometer, Manual", a Class II medical device regulated under 21 CFR 886.1930. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HKY
- Device Class
- Class II
- Regulation Number
- 886.1930
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241447 | icare finland | iCare ST500 (TA04) | September 27, 2024 |
| K233516 | reichert | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) | May 1, 2024 |
| K234037 | cats tonometer | CATS-L Tonometer Prism | February 9, 2024 |
| K232143 | huvitz co | Applanation Tonometer HT-5000 | October 23, 2023 |
| K220852 | icare finland | iCare IC200 | October 6, 2022 |
| K211355 | icare finland | iCare HOME2 | January 25, 2022 |
| K203850 | cats tonometer | CATS®-D Tonometer Prism | June 14, 2021 |
| K200966 | icare finland | Icare HOME Tonometer | May 7, 2020 |
| K190316 | icare finland | Icare ic200 | January 14, 2020 |
| K191314 | chongqing sunkingdom medical instrument co | Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q | December 19, 2019 |
| K182491 | takagi seiko co | Applanation tonometer AT-2 | December 10, 2018 |
| K180839 | carl zeiss meditec | AT 030 | June 7, 2018 |
| K173904 | cats tonometer | CATS Tonometer Prism | March 9, 2018 |
| K172728 | takagi seiko co | Applanation tonometer AT-1 | October 17, 2017 |
| K163343 | icare finland | Icare HOME tonometer | March 21, 2017 |
| K153694 | icare finland | Icare ic100 | April 19, 2016 |
| K142263 | shanghai mediworks precision instruments co. | Applanation Tonometer | April 15, 2016 |
| K151491 | falck medical | Falck Medical Multifunction Tonometer, FAT1 | January 15, 2016 |
| K152644 | keeler limited | KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 | December 31, 2015 |
| K152308 | sensor medical technology | Sensor Medical Single Use Tonometer Prism | October 13, 2015 |