Panels › Ophthalmic › Product code HKY · Class 2
Tonometer, Manual
Regulation 886.1930
0510(k)s in 12 months (56 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in HKY
| Company | 510(k)s | Recalls |
|---|---|---|
| Icare Finland OY | 7 | 0 |
| Keeler Limited | 4 | 0 |
| Cats Tonometer, LLC | 3 | 0 |
| Falck Medical, Inc. | 2 | 0 |
| Instrumed International, Inc. | 0 | 2 |
| Oculab, Inc. | 2 | 0 |
| Reichert, Inc. | 2 | 0 |
| Takagi Seiko Co., Ltd. | 2 | 0 |
| Accutome, Inc. | 1 | 0 |
| Automated Ophthalmics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 27, 2024 | K241447 | iCare ST500 (TA04) Icare Finland OY, FI | HKY |
| May 1, 2024 | K233516 | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) Reichert, Inc. | HKY |
| Feb 9, 2024 | K234037 | CATS-L Tonometer Prism Cats Tonometer, LLC | HKY |
| Oct 23, 2023 | K232143 | Applanation Tonometer HT-5000 Huvitz Co., Ltd., KR | HKY |
| Oct 6, 2022 | K220852 | iCare IC200 Icare Finland OY, FI | HKY |
| Jan 25, 2022 | K211355 | iCare HOME2 Icare Finland OY, FI | HKY |
| Jun 14, 2021 | K203850 | CATS®-D Tonometer Prism Cats Tonometer, LLC | HKY |
| May 7, 2020 | K200966 | Icare HOME Tonometer Icare Finland OY, FI | HKY |
| Jan 14, 2020 | K190316 | Icare ic200 Icare Finland OY, FI | HKY |
| Dec 19, 2019 | K191314 | Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q Chongqing Sunkingdom Medical Instrument Co., Ltd., CN | HKY |
| Dec 10, 2018 | K182491 | Applanation tonometer AT-2 Takagi Seiko Co., Ltd., JP | HKY |
| Jun 7, 2018 | K180839 | AT 030 Carl Zeiss Meditec, AG, DE | HKY |
| Mar 9, 2018 | K173904 | CATS Tonometer Prism Cats Tonometer, LLC | HKY |
| Oct 17, 2017 | K172728 | Applanation tonometer AT-1 Takagi Seiko Co., Ltd., JP | HKY |
| Mar 21, 2017 | K163343 | Icare HOME tonometer Icare Finland OY, FI | HKY |
| Apr 19, 2016 | K153694 | Icare ic100 Icare Finland OY, FI | HKY |
| Apr 15, 2016 | K142263 | Applanation Tonometer Shanghai Mediworks Precision Instruments Co. , Ltd., CN | HKY |
| Jan 15, 2016 | K151491 | Falck Medical Multifunction Tonometer, FAT1 Falck Medical, Inc. | HKY |
| Dec 31, 2015 | K152644 | KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 Keeler Limited, GB | HKY |
| Oct 13, 2015 | K152308 | Sensor Medical Single Use Tonometer Prism Sensor Medical Technology, LLC | HKY |
| Sep 17, 2014 | K142179 | D-KAT Z-YPE Keeler, Ltd. | HKY |
| Apr 23, 2014 | K132549 | ACCUTIP COVER Accutome, Inc. | HKY |
| Feb 21, 2014 | K133234 | T-TYPE D-KAT, R-TYPE D-KAT Keeler Limited | HKY |
| Dec 20, 2013 | K132917 | OCULAR FORCE GAUGE Ocular Therapeutix, Inc. | HKY |
| Jan 19, 2010 | K093445 | KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT) Keeler, Ltd. | HKY |
| Jun 3, 2008 | K071755 | FALCK APPLANATION TONOMETER (FAT2) Falck Medical, Inc. | HKY |
| May 23, 2007 | K063873 | ICARE TONOMETER TA01I Tiolat OY | HKY |
| Mar 27, 2007 | K070534 | MODIFICATION TO: OCU-FILM TIP COVER Reichert, Inc. | HKY |
| Mar 3, 2006 | K053430 | TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER Medtronic Xomed, Inc. | HKY |
| Nov 23, 2004 | K033146 | TONO-PEN TONOMETER TIP COVER Tra & Accessories | HKY |
| Nov 14, 2003 | K032967 | PASCAL DYNAMIC CONTOUR TONOMETER Smt Swiss Microtechnology AG | HKY |
| Sep 23, 2003 | K032769 | EYESOPEN TONOMETER Eye-Deas, LLC | HKY |
| Feb 20, 2003 | K023838 | LUNEAU STERILE TONOMETER SEPARATION PRISMS Luneau SA, FR | HKY |
| Aug 6, 2002 | K022054 | F 900 C.S.O. S.R.L. | HKY |
| Jul 2, 2001 | K011199 | PROVIEW EYE PRESSURE MONITOR Bausch & Lomb, Inc. | HKY |
| Jun 6, 2000 | K992835 | C.S.O. TONOMETER Cso | HKY |
| Mar 23, 2000 | K000288 | REICHERT CT200 CONTACT TONOMETER Reichert Ophthalmic Instruments, Div. Leica, Inc. | HKY |
| Mar 20, 2000 | K991840 | FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER Bernard B. Fresco, CA | HKY |
| Jan 10, 2000 | K992998 | AUTOMATED OPHTHALMICS SOFTIPS Automated Ophthalmics, Inc. | HKY |
| Jan 12, 1999 | K981432 | GOLDMAN MANUAL TONOMETER Golden Vision, Inc. | HKY |
| Jun 17, 1997 | K970887 | BLOOD FLOW ANALYZER Paradigm Medical Industries, Inc. | HKY |
| Nov 26, 1996 | K964312 | MENTOR TONO-PEN 3 Mentor Ophthalmics, Inc. | HKY |
| Jul 18, 1996 | K961512 | PERKINS HAND-HELD APPLANATION TONOMETER Clement Clarke, Inc., GB | HKY |
| Jun 4, 1996 | K960924 | KOWA HAND-HELD APPLANATION TONOMETER HA-1 Kowa Optimed, Inc. | HKY |
| Jun 20, 1995 | K945446 | BOBES TONOMETER Bobes S.A., ES | HKY |
| May 8, 1995 | K945541 | SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE Rudolf Riester GmbH & Co. KG, DE | HKY |
| Apr 5, 1993 | K924760 | TOMEY PROTON TONOMETER Tomey Corporation USA | HKY |
| Sep 30, 1992 | K923877 | TONOSHIELD TONOMETER SHIELD Oasis Medical, Inc. | HKY |
| Aug 4, 1988 | K882750 | OCU-FILM TIP COVER Oculab, Inc. | HKY |
| Feb 12, 1986 | K860330 | MAKLAKOV STYLE TONOMETER Med-Tech Develoment Corp. | HKY |
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