Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1930](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1930) → HKY — Tonometer, Manual # HKY · Tonometer, Manual _Ophthalmic · 21 CFR 886.1930 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY ## Overview - **Product Code:** HKY - **Device Name:** Tonometer, Manual - **Regulation:** [21 CFR 886.1930](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1930) - **Device Class:** 2 - **Review Panel:** [Ophthalmic](/submissions/OP) - **3rd-party reviewable:** yes ## Identification A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 56) Showing 20 most recent of 56 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K241447](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY/K241447.md) | iCare ST500 (TA04) | Icare Finland OY | Sep 27, 2024 | SESE | | [K233516](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY/K233516.md) | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) | Reichert, Inc. | May 1, 2024 | SESE | | [K234037](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY/K234037.md) | CATS-L Tonometer™ Prism | Cats Tonometer, LLC | Feb 9, 2024 | SESE | | [K232143](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY/K232143.md) | Applanation Tonometer HT-5000 | Huvitz Co., Ltd. | Oct 23, 2023 | SESE | | [K220852](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY/K220852.md) | iCare IC200 | Icare Finland OY | Oct 6, 2022 | SESE | | [K211355](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY/K211355.md) | iCare HOME2 | Icare Finland OY | Jan 25, 2022 | SESE | | [K203850](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY/K203850.md) | CATS®-D Tonometer Prism | Cats Tonometer, LLC | Jun 14, 2021 | SESE | | [K200966](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY/K200966.md) | Icare HOME Tonometer | Icare Finland OY | May 7, 2020 | SESE | | [K190316](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY/K190316.md) | Icare ic200 | Icare Finland OY | Jan 14, 2020 | SESE | | [K191314](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY/K191314.md) | Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q | Chongqing Sunkingdom Medical Instrument Co., Ltd. | Dec 19, 2019 | SESE | | [K182491](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY/K182491.md) | Applanation tonometer AT-2 | Takagi Seiko Co., Ltd. | Dec 10, 2018 | SESE | | [K180839](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY/K180839.md) | AT 030 | Carl Zeiss Meditec, AG | Jun 7, 2018 | SESE | | [K173904](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY/K173904.md) | CATS Tonometer Prism | Cats Tonometer, LLC | Mar 9, 2018 | SESE | | [K172728](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY/K172728.md) | Applanation tonometer AT-1 | Takagi Seiko Co., Ltd. | Oct 17, 2017 | SESE | | [K163343](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY/K163343.md) | Icare HOME tonometer | Icare Finland OY | Mar 21, 2017 | SESE | | [K153694](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY/K153694.md) | Icare ic100 | Icare Finland OY | Apr 19, 2016 | SESE | | [K142263](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY/K142263.md) | Applanation Tonometer | Shanghai Mediworks Precision Instruments Co. , Ltd. | Apr 15, 2016 | SESE | | [K151491](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY/K151491.md) | Falck Medical Multifunction Tonometer, FAT1 | Falck Medical, Inc. | Jan 15, 2016 | SESE | | [K152644](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY/K152644.md) | KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 | Keeler Limited | Dec 31, 2015 | SESE | | [K152308](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY/K152308.md) | Sensor Medical Single Use Tonometer Prism | Sensor Medical Technology, LLC | Oct 13, 2015 | SESE | ## Top Applicants - Icare Finland OY — 7 clearances - Cats Tonometer, LLC — 3 clearances - Falck Medical, Inc. — 2 clearances - Keeler Limited — 2 clearances - Keeler, Ltd. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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