Product code HKY
- Device name
- Tonometer, Manual
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.1930
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241447 | iCare ST500 (TA04) | Icare Finland OY | 2024-09-27 |
| K233516 | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) | Reichert, Inc. | 2024-05-01 |
| K234037 | CATS-L Tonometer™ Prism | Cats Tonometer, LLC | 2024-02-09 |
| K232143 | Applanation Tonometer HT-5000 | Huvitz Co., Ltd. | 2023-10-23 |
| K220852 | iCare IC200 | Icare Finland OY | 2022-10-06 |
| K211355 | iCare HOME2 | Icare Finland OY | 2022-01-25 |
| K203850 | CATS®-D Tonometer Prism | Cats Tonometer, LLC | 2021-06-14 |
| K200966 | Icare HOME Tonometer | Icare Finland OY | 2020-05-07 |
| K190316 | Icare ic200 | Icare Finland OY | 2020-01-14 |
| K191314 | Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2019-12-19 |
| K182491 | Applanation tonometer AT-2 | Takagi Seiko Co., Ltd. | 2018-12-10 |
| K180839 | AT 030 | Carl Zeiss Meditec, AG | 2018-06-07 |
| K173904 | CATS Tonometer Prism | Cats Tonometer, LLC | 2018-03-09 |
| K172728 | Applanation tonometer AT-1 | Takagi Seiko Co., Ltd. | 2017-10-17 |
| K163343 | Icare HOME tonometer | Icare Finland OY | 2017-03-21 |
| K153694 | Icare ic100 | Icare Finland OY | 2016-04-19 |
| K142263 | Applanation Tonometer | Shanghai Mediworks Precision Instruments Co. , Ltd. | 2016-04-15 |
| K151491 | Falck Medical Multifunction Tonometer, FAT1 | Falck Medical, Inc. | 2016-01-15 |
| K152644 | KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 | Keeler Limited | 2015-12-31 |
| K152308 | Sensor Medical Single Use Tonometer Prism | Sensor Medical Technology, LLC | 2015-10-13 |
| K142179 | D-KAT Z-YPE | Keeler, Ltd. | 2014-09-17 |
| K132549 | ACCUTIP COVER | Accutome, Inc. | 2014-04-23 |
| K133234 | T-TYPE D-KAT, R-TYPE D-KAT | Keeler Limited | 2014-02-21 |
| K132917 | OCULAR FORCE GAUGE | Ocular Therapeutix, Inc. | 2013-12-20 |
| K093445 | KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT) | Keeler, Ltd. | 2010-01-19 |
| K071755 | FALCK APPLANATION TONOMETER (FAT2) | Falck Medical, Inc. | 2008-06-03 |
| K063873 | ICARE TONOMETER TA01I | Tiolat OY | 2007-05-23 |
| K070534 | MODIFICATION TO: OCU-FILM TIP COVER | Reichert, Inc. | 2007-03-27 |
| K053430 | TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER | Medtronic Xomed, Inc. | 2006-03-03 |
| K033146 | TONO-PEN TONOMETER TIP COVER | Tra & Accessories | 2004-11-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10841668146474 | KATENA | KATENA PRODUCTS, INC. | 2026-03-02 |
| 00841668146477 | KATENA | KATENA PRODUCTS, INC. | 2026-03-02 |
| 06430033851920 | iCare ST500 | ICARE FINLAND OY | 2025-12-05 |
| 06430033852415 | iCare IC100 | ICARE FINLAND OY | 2025-12-04 |
| 06430033852514 | iCare IC200 | ICARE FINLAND OY | 2025-12-04 |
| 00812559012485 | " Ocu-Film® +""" | REICHERT, INC. | 2025-08-15 |
| 00812559012492 | "Ocu-Film® +""" | REICHERT, INC. | 2025-08-14 |
| 00812559012454 | Ocu-Dot® Tonometer Probes - 100 Count | REICHERT, INC. | 2025-08-12 |
| 06430033851883 | iCare ST500 | ICARE FINLAND OY | 2024-11-07 |
| 06430033851807 | ST500 Remote | ICARE FINLAND OY | 2024-11-07 |
| 06430033851784 | ST500 SmartCradle | ICARE FINLAND OY | 2024-11-07 |
| 06430033851791 | ST500 Adapter | ICARE FINLAND OY | 2024-11-07 |
| 03664188000138 | Luneau | LUNEAU TECHNOLOGY OPERATIONS | 2023-06-08 |
| 00860412001541 | CATS | ZIEN MEDICAL TECHNOLOGIES, INC. | 2022-10-12 |
| 06973211070671 | Applanation Tonometer | CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD | 2020-07-02 |
| 06973211070664 | Applanation Tonometer | CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD | 2020-07-02 |
| 06973211070657 | Applanation Tonometer | CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD | 2020-07-02 |
| 06430033850947 | Probes for HOME | ICARE FINLAND OY | 2020-04-15 |
| 06430033850626 | Probes for HOME | ICARE FINLAND OY | 2017-03-24 |
| 06430033850237 | Icare HOME tonometer | ICARE FINLAND OY | 2017-03-24 |
| 16430033850623 | Probes for HOME | ICARE FINLAND OY | 2017-03-24 |
| 06430033850565 | Icare tonometer probes | ICARE FINLAND OY | 2016-12-01 |
| 06430033850473 | Icare ic100 | ICARE FINLAND OY | 2016-09-23 |
| 06430033850060 | Icare TA01i | ICARE FINLAND OY | 2016-09-23 |
| 04045396131118 | schiötz C tonometer, inclined scale, silver, with 4 weights | Rudolf Riester GmbH | 2016-09-20 |
| 04045396131101 | schiötz C tonometer, inclined scale, gold | Rudolf Riester GmbH | 2016-09-20 |
| 04045396007109 | schiötz C tonometer, inclined scale, silver | Rudolf Riester GmbH | 2016-09-20 |
| 04045396007093 | schiötz B tonometer, inclined scale, silver | Rudolf Riester GmbH | 2016-09-20 |
| 04045396007086 | schiötz A tonometer, straight scale, silver | Rudolf Riester GmbH | 2016-09-20 |
| 10381780159544 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |