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HKX

58 FDA 510(k) clearances · Product code

106 daysmedian time to decision
330 days90th percentile
58clearances measured

FDA profile

Official device name
Tonometer, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1930
Medical specialty
Ophthalmic
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RecordFirmDate
AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA (K253039)Topcon Corporation2025-11-07
VS Tabletop Tonometer (K223739)Medimaging Integrated Solution, Inc.2023-11-08
Intraocular Pressure Tonometer EASYTON (K190382)Company Elamed2019-12-06
MiiS Horus Scope DPT 100 (K181260)Medimaging Integrated Solution, Inc (Miis)2019-06-21
Keeler TonoCare Tonometer (K181143)Keeler Instruments, Inc.2019-02-08
Tono Vue Non-Contact Tonometer (K180820)Crystalvue Medical Corporation2018-12-14
VX130 Ophthalmic Diagnostic Device (K162067)Luneau Sas2017-04-24
VX120 Ophthalmic Diagnostic Device (K143086)Luneau Sas2015-06-01
CORVIS ST (K113066)Oculus Optikgerate GmbH2012-11-08
FULL AUTO TONOMETER MODEL TX-20 (K111710)Canon Inc. -Medical Equipment Group2011-09-20
PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 (K093298)Keeler Instruments, Inc.2010-12-10
ACCUPEN (K083377)Accutome Ultrasound, Inc.2009-07-27
NON-CONTACT TONOMETER, MODEL FT-1000 (K073087)Tomey Corporation2008-11-18
OCULAR RESPONSE ANALYZER (K081756)Reichert, Inc.2008-08-07
KOWA KT-800 (K053444)Kowa Co. , Ltd.2006-06-09
TONOMETER DIATON (K060780)Ryazan State Instruments2006-04-06
TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) (K042099)Retinapharma Technologies, Inc.2004-12-10
NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER (K032799)Reichert, Inc.2004-01-20
NON-CONTACT TONOMETER, MODEL NT-4000 (K031733)Nidek, Inc.2003-12-04
APPLANATION TONOMETER (K023676)Optilasa, S.L.2003-04-24
CANON FULL AUTO TONOMETER TX-F (K023816)Canon, Inc.-Utsunomiya Optical Products Operation2002-11-26
KOWA AUTOMATED TONOMETER KT-500 (K013805)Kowa Optimed, Inc.2002-10-11
TGDC-01 PRA (K021937)Truevision Instruments2002-10-11
PORTABLE NON-CONTACT TONOMETER, MODEL PT100 (K013259)Leica Microsystems, Inc. O.I.D.2002-02-20
LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201 (K010998)Langham Ophthalmic Technologies2001-06-27
MODEL 30 CLASSIC PNEUMATONOMETER (K002395)Xomed, Inc.2000-12-11
SMARTLENS (K002510)Odc Ophthalmic Development Co. AG2000-10-18
LEICA AT550 (K990869)Leica Microsystems, Inc.1999-06-07
KEELER PULSAIR 3000 NON CONTACT TONOMETER (K990257)Keeler Instruments, Inc.1999-03-25
CANON TX-10 TONOMETER (K963079)Canon USA, Inc.1997-03-03
ZEIMER SELF TONOMETER (K953031)Cds Technologies1995-08-22
DIGITAL AVERAGING TONOMETER (K945972)Opti-Med Electronics1995-08-17
NON-CONTACT TONOMETER T-2 (K943939)Canon, Inc.1995-05-12
XPERT NCT (K941865)Reichert Ophthalmic Instruments, Div. Leica, Inc.1994-09-29
TIP & MEMBRANE ASSEMBLY (K921443)Bio-Rad1993-06-22
BURTON APPLANATION TONOMETER - MODEL T850 & T1000 (K924777)R.H. Burton Co.1993-04-05
CYLINDER OF GAS, CAN OF GAS (CC12F2) (K921617)Bio-Rad1992-08-05
NIDEK MODEL NT-1000 (K913189)Nidek, Inc.1991-10-15
KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION (K911721)Keeler Instruments, Inc.1991-06-25
BIO-RAD MODULAR AIR COMPRESSOR (K895575)Bio-Rad1989-10-31
MMAC II TONOMETER (K884012)Professional Technologies Corp.1989-01-06
OBF MODEL 115 COMPUTER TONOMETER SYSTEM (K873422)Ocular Blood Flow Laboratories, Inc.1987-11-02
TONOMETER TAPES (K873917)Richmond Products, Inc.1987-11-02
T P C (TONOMETER PROBE COVER) (K871935)Krb Ent.1987-06-03
TOPCON COMPUTERIZED TONOMETER CT-10 (K871335)Topcon Instrument Corporation of America1987-05-18
KEELER PULSAIR NON CONTACT TONOMETER (K870750)Keeler Instruments, Inc.1987-03-17
DIGILAB MICRO ONE APPLANATION TONOMETER (K870121)Bio-Rad1987-02-20
OBF MODEL 112 VACUUM CUP SYSTEM (K864959)Ocular Blood Flow Laboratories, Inc.1987-02-12
SURGICAL IOP MONITOR (K863235)Ameritek, Inc.1986-09-25
DIGILAB MODULAR ONE-APPLANATION TONOMETER (K863217)Bio-Rad1986-09-24
COMPUTON(R) (K863200)Optical Radiation Corp.1986-09-03
EPISCLERAL VENOUS PRESSURE (K843354)Eyetech, LLC1984-11-19
WOODLYN APPLANATION TONOMETER (K841762)Woodlyn, Inc.1984-08-02
CAT 100 (K840836)CooperVision, Inc.1984-06-19
CLERZ LUBRICATING/REWETTING SOLUTION (K833494)CooperVision, Inc.1984-01-04
GLAUKON (K820751)Sonometrics Systems, Inc.1982-04-09
AO NON-CONTACT II TONOMETER (K802419)American Optical Corp.1980-11-12
SPAN-AID BRIDGING PILLOW SYSTEM (K801518)Span-America Medical Systems, Inc.1980-08-04

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