Product Code: HKX FDA class 2 21 CFR 886.1930

Tonometer, Ac-Powered

Ophthalmic

The AC-Powered Tonometer is an electrically powered instrument used to measure intraocular pressure (IOP), a critical parameter in the diagnosis and management of glaucoma and other conditions affecting ocular pressure. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance demonstrating substantial equivalence to a predicate device. The product code is HKX, regulated under 21 CFR 886.1930, within the Ophthalmic medical specialty. No special risk flags apply to this device.

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FEI Numbers

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Basic Information

Product Code: HKX
Device Class: FDA class 2
Regulation Number: 886.1930
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 58 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253039	AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA	Nov 07, 2025	Substantially Equivalent	Topcon Corporation
K223739	VS Tabletop Tonometer	Nov 08, 2023	Substantially Equivalent	Medimaging Integrated Solution, Inc.
K190382	Intraocular Pressure Tonometer EASYTON	Dec 06, 2019	Substantially Equivalent	Company Elamed
K181260	MiiS Horus Scope DPT 100	Jun 21, 2019	Substantially Equivalent	Medimaging Integrated Solution, Inc (Miis)
K181143	Keeler TonoCare Tonometer	Feb 08, 2019	Substantially Equivalent	Keeler Instruments, Inc.
K180820	Tono Vue Non-Contact Tonometer	Dec 14, 2018	Substantially Equivalent	Crystalvue Medical Corporation
K162067	VX130 Ophthalmic Diagnostic Device	Apr 24, 2017	Substantially Equivalent	Luneau Sas
K143086	VX120 Ophthalmic Diagnostic Device	Jun 01, 2015	Substantially Equivalent	Luneau Sas
K113066	CORVIS ST	Nov 08, 2012	Substantially Equivalent	Oculus Optikgerate GmbH
K111710	FULL AUTO TONOMETER MODEL TX-20	Sep 20, 2011	Substantially Equivalent	Canon Inc. -Medical Equipment Group
K093298	PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000	Dec 10, 2010	Substantially Equivalent	Keeler Instruments, Inc.
K083377	ACCUPEN	Jul 27, 2009	Substantially Equivalent	Accutome Ultrasound, Inc.
K073087	NON-CONTACT TONOMETER, MODEL FT-1000	Nov 18, 2008	Substantially Equivalent	Tomey Corporation
K081756	OCULAR RESPONSE ANALYZER	Aug 07, 2008	Substantially Equivalent	Reichert, Inc.
K053444	KOWA KT-800	Jun 09, 2006	Substantially Equivalent	Kowa Co. , Ltd.
K060780	TONOMETER DIATON	Apr 06, 2006	Substantially Equivalent	Ryazan State Instruments
K042099	TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)	Dec 10, 2004	Substantially Equivalent	Retinapharma Technologies, Inc.
K032799	NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER	Jan 20, 2004	Substantially Equivalent	Reichert, Inc.
K031733	NON-CONTACT TONOMETER, MODEL NT-4000	Dec 04, 2003	Substantially Equivalent	Nidek, Inc.
K023676	APPLANATION TONOMETER	Apr 24, 2003	Substantially Equivalent	Optilasa, S.L.
K023816	CANON FULL AUTO TONOMETER TX-F	Nov 26, 2002	Substantially Equivalent	Canon, Inc.-Utsunomiya Optical Products Operation
K021937	TGDC-01 PRA	Oct 11, 2002	Substantially Equivalent	Truevision Instruments
K013805	KOWA AUTOMATED TONOMETER KT-500	Oct 11, 2002	Substantially Equivalent	Kowa Optimed, Inc.
K013259	PORTABLE NON-CONTACT TONOMETER, MODEL PT100	Feb 20, 2002	Substantially Equivalent	Leica Microsystems, Inc. O.I.D.
K010998	LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201	Jun 27, 2001	Unknown	Langham Ophthalmic Technologies
K002395	MODEL 30 CLASSIC PNEUMATONOMETER	Dec 11, 2000	Substantially Equivalent	Xomed, Inc.
K002510	SMARTLENS	Oct 18, 2000	Substantially Equivalent	Odc Ophthalmic Development Co. AG
K990869	LEICA AT550	Jun 07, 1999	Substantially Equivalent	Leica Microsystems, Inc.
K990257	KEELER PULSAIR 3000 NON CONTACT TONOMETER	Mar 25, 1999	Substantially Equivalent	Keeler Instruments, Inc.
K963079	CANON TX-10 TONOMETER	Mar 03, 1997	Substantially Equivalent	Canon USA, Inc.
K953031	ZEIMER SELF TONOMETER	Aug 22, 1995	Substantially Equivalent	Cds Technologies
K945972	DIGITAL AVERAGING TONOMETER	Aug 17, 1995	Substantially Equivalent	Opti-Med Electronics
K943939	NON-CONTACT TONOMETER T-2	May 12, 1995	Substantially Equivalent	Canon, Inc.
K941865	XPERT NCT	Sep 29, 1994	Substantially Equivalent	Reichert Ophthalmic Instruments, Div. Leica, Inc.
K921443	TIP & MEMBRANE ASSEMBLY	Jun 22, 1993	Substantially Equivalent	Bio-Rad
K924777	BURTON APPLANATION TONOMETER - MODEL T850 & T1000	Apr 05, 1993	Substantially Equivalent	R.H. Burton Co.
K921617	CYLINDER OF GAS, CAN OF GAS (CC12F2)	Aug 05, 1992	Substantially Equivalent	Bio-Rad
K913189	NIDEK MODEL NT-1000	Oct 15, 1991	Substantially Equivalent	Nidek, Inc.
K911721	KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION	Jun 25, 1991	Substantially Equivalent	Keeler Instruments, Inc.
K895575	BIO-RAD MODULAR AIR COMPRESSOR	Oct 31, 1989	Substantially Equivalent	Bio-Rad
K884012	MMAC II TONOMETER	Jan 06, 1989	Substantially Equivalent	Professional Technologies Corp.
K873917	TONOMETER TAPES	Nov 02, 1987	Substantially Equivalent	Richmond Products, Inc.
K873422	OBF MODEL 115 COMPUTER TONOMETER SYSTEM	Nov 02, 1987	Substantially Equivalent	Ocular Blood Flow Laboratories, Inc.
K871935	T P C (TONOMETER PROBE COVER)	Jun 03, 1987	Substantially Equivalent	Krb Ent.
K871335	TOPCON COMPUTERIZED TONOMETER CT-10	May 18, 1987	Substantially Equivalent	Topcon Instrument Corporation of America
K870750	KEELER PULSAIR NON CONTACT TONOMETER	Mar 17, 1987	Substantially Equivalent	Keeler Instruments, Inc.
K870121	DIGILAB MICRO ONE APPLANATION TONOMETER	Feb 20, 1987	Substantially Equivalent	Bio-Rad
K864959	OBF MODEL 112 VACUUM CUP SYSTEM	Feb 12, 1987	Substantially Equivalent	Ocular Blood Flow Laboratories, Inc.
K863235	SURGICAL IOP MONITOR	Sep 25, 1986	Substantially Equivalent	Ameritek, Inc.
K863217	DIGILAB MODULAR ONE-APPLANATION TONOMETER	Sep 24, 1986	Substantially Equivalent	Bio-Rad
K863200	COMPUTON(R)	Sep 03, 1986	Substantially Equivalent	Optical Radiation Corp.
K843354	EPISCLERAL VENOUS PRESSURE	Nov 19, 1984	Substantially Equivalent	Eyetech, LLC
K841762	WOODLYN APPLANATION TONOMETER	Aug 02, 1984	Substantially Equivalent	Woodlyn, Inc.
K840836	CAT 100	Jun 19, 1984	Substantially Equivalent	CooperVision, Inc.
K833494	CLERZ LUBRICATING/REWETTING SOLUTION	Jan 04, 1984	Substantially Equivalent	CooperVision, Inc.
K820751	GLAUKON	Apr 09, 1982	Substantially Equivalent	Sonometrics Systems, Inc.
K802419	AO NON-CONTACT II TONOMETER	Nov 12, 1980	Substantially Equivalent	American Optical Corp.
K801518	SPAN-AID BRIDGING PILLOW SYSTEM	Aug 04, 1980	Substantially Equivalent	Span-America Medical Systems, Inc.