Atlas FDA

HKY

56 FDA 510(k) clearances · Product code

94 daysmedian time to decision
288 days90th percentile
56clearances measured

FDA profile

Official device name
Tonometer, Manual
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1930
Medical specialty
Ophthalmic
Flags
Third-party review eligible
Adverse events (MAUDE)
1998: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
iCare ST500 (TA04) (K241447)Icare Finland OY2024-09-27
Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) (K233516)Reichert, Inc.2024-05-01
CATS-L Tonometer™ Prism (K234037)Cats Tonometer, LLC2024-02-09
Applanation Tonometer HT-5000 (K232143)Huvitz Co., Ltd.2023-10-23
iCare IC200 (K220852)Icare Finland OY2022-10-06
iCare HOME2 (K211355)Icare Finland OY2022-01-25
CATS®-D Tonometer Prism (K203850)Cats Tonometer, LLC2021-06-14
Icare HOME Tonometer (K200966)Icare Finland OY2020-05-07
Icare ic200 (K190316)Icare Finland OY2020-01-14
Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q (K191314)Chongqing Sunkingdom Medical Instrument Co., Ltd.2019-12-19
Applanation tonometer AT-2 (K182491)Takagi Seiko Co., Ltd.2018-12-10
AT 030 (K180839)Carl Zeiss Meditec, AG2018-06-07
CATS Tonometer Prism (K173904)Cats Tonometer, LLC2018-03-09
Applanation tonometer AT-1 (K172728)Takagi Seiko Co., Ltd.2017-10-17
Icare HOME tonometer (K163343)Icare Finland OY2017-03-21
Icare ic100 (K153694)Icare Finland OY2016-04-19
Applanation Tonometer (K142263)Shanghai Mediworks Precision Instruments Co. , Ltd.2016-04-15
Falck Medical Multifunction Tonometer, FAT1 (K151491)Falck Medical, Inc.2016-01-15
KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 (K152644)Keeler Limited2015-12-31
Sensor Medical Single Use Tonometer Prism (K152308)Sensor Medical Technology, LLC2015-10-13
D-KAT Z-YPE (K142179)Keeler, Ltd.2014-09-17
ACCUTIP COVER (K132549)Accutome, Inc.2014-04-23
T-TYPE D-KAT, R-TYPE D-KAT (K133234)Keeler Limited2014-02-21
OCULAR FORCE GAUGE (K132917)Ocular Therapeutix, Inc.2013-12-20
KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT) (K093445)Keeler, Ltd.2010-01-19
FALCK APPLANATION TONOMETER (FAT2) (K071755)Falck Medical, Inc.2008-06-03
ICARE TONOMETER TA01I (K063873)Tiolat OY2007-05-23
MODIFICATION TO: OCU-FILM TIP COVER (K070534)Reichert, Inc.2007-03-27
TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER (K053430)Medtronic Xomed, Inc.2006-03-03
TONO-PEN TONOMETER TIP COVER (K033146)Tra & Accessories2004-11-23
PASCAL DYNAMIC CONTOUR TONOMETER (K032967)Smt Swiss Microtechnology AG2003-11-14
EYESOPEN TONOMETER (K032769)Eye-Deas, LLC2003-09-23
LUNEAU STERILE TONOMETER SEPARATION PRISMS (K023838)Luneau SA2003-02-20
F 900 (K022054)C.S.O. S.R.L.2002-08-06
PROVIEW EYE PRESSURE MONITOR (K011199)Bausch & Lomb, Inc.2001-07-02
C.S.O. TONOMETER (K992835)Cso2000-06-06
REICHERT CT200 CONTACT TONOMETER (K000288)Reichert Ophthalmic Instruments, Div. Leica, Inc.2000-03-23
FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER (K991840)Bernard B. Fresco2000-03-20
AUTOMATED OPHTHALMICS SOFTIPS (K992998)Automated Ophthalmics, Inc.2000-01-10
GOLDMAN MANUAL TONOMETER (K981432)Golden Vision, Inc.1999-01-12
BLOOD FLOW ANALYZER (K970887)Paradigm Medical Industries, Inc.1997-06-17
MENTOR TONO-PEN 3 (K964312)Mentor Ophthalmics, Inc.1996-11-26
PERKINS HAND-HELD APPLANATION TONOMETER (K961512)Clement Clarke, Inc.1996-07-18
KOWA HAND-HELD APPLANATION TONOMETER HA-1 (K960924)Kowa Optimed, Inc.1996-06-04
BOBES TONOMETER (K945446)Bobes S.A.1995-06-20
SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE (K945541)Rudolf Riester GmbH & Co. KG1995-05-08
TOMEY PROTON TONOMETER (K924760)Tomey Corporation USA1993-04-05
TONOSHIELD TONOMETER SHIELD (K923877)Oasis Medical, Inc.1992-09-30
OCU-FILM TIP COVER (K882750)Oculab, Inc.1988-08-04
MAKLAKOV STYLE TONOMETER (K860330)Med-Tech Develoment Corp.1986-02-12
OCULAB TONOPEN (K852774)Oculab, Inc.1985-08-20
JAKOBI SURG. INSTRUMENTS #6 50 (K834187)Imm Enterprises , Ltd.1984-03-05
SURGICAL IOP MONITOR (K832996)Miami Eye Technology, Inc.1983-11-28
CONPHAR-SCHIOETZ TONOMETER (K813619)Conphar, Inc.1982-02-24
TONOMETER, DIGITON (K781105)Ical, Inc.1978-09-27
OCULAR CEREBRAL VASCULAR MONITOR (K772130)Digilab, Inc.1977-11-28

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Every clearance here is in the API, with alerts when new ones post.