Product Code: HKY FDA class 2 21 CFR 886.1930

Tonometer, Manual

Ophthalmic

The Manual Tonometer is a hand-held or mechanical instrument used to measure intraocular pressure without reliance on electrical power, used in the routine screening and management of glaucoma and elevated IOP conditions. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is HKY, regulated under 21 CFR 886.1930, within the Ophthalmic medical specialty. This device is eligible for third-party 510(k) review by an FDA-accredited reviewer.

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FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

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

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 56 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K241447	iCare ST500 (TA04)	Sep 27, 2024	Substantially Equivalent	Icare Finland OY
K233516	Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)	May 01, 2024	Substantially Equivalent	Reichert, Inc.
K234037	CATS-L Tonometer Prism	Feb 09, 2024	Substantially Equivalent	Cats Tonometer, LLC
K232143	Applanation Tonometer HT-5000	Oct 23, 2023	Substantially Equivalent	Huvitz Co., Ltd.
K220852	iCare IC200	Oct 06, 2022	Substantially Equivalent	Icare Finland OY
K211355	iCare HOME2	Jan 25, 2022	Substantially Equivalent	Icare Finland OY
K203850	CATS®-D Tonometer Prism	Jun 14, 2021	Substantially Equivalent	Cats Tonometer, LLC
K200966	Icare HOME Tonometer	May 07, 2020	Substantially Equivalent	Icare Finland OY
K190316	Icare ic200	Jan 14, 2020	Substantially Equivalent	Icare Finland OY
K191314	Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q	Dec 19, 2019	Substantially Equivalent	Chongqing Sunkingdom Medical Instrument Co., Ltd.
K182491	Applanation tonometer AT-2	Dec 10, 2018	Substantially Equivalent	Takagi Seiko Co., Ltd.
K180839	AT 030	Jun 07, 2018	Substantially Equivalent	Carl Zeiss Meditec, AG
K173904	CATS Tonometer Prism	Mar 09, 2018	Substantially Equivalent	Cats Tonometer, LLC
K172728	Applanation tonometer AT-1	Oct 17, 2017	Substantially Equivalent	Takagi Seiko Co., Ltd.
K163343	Icare HOME tonometer	Mar 21, 2017	Substantially Equivalent	Icare Finland OY
K153694	Icare ic100	Apr 19, 2016	Substantially Equivalent	Icare Finland OY
K142263	Applanation Tonometer	Apr 15, 2016	Substantially Equivalent	Shanghai Mediworks Precision Instruments Co. , Ltd.
K151491	Falck Medical Multifunction Tonometer, FAT1	Jan 15, 2016	Substantially Equivalent	Falck Medical, Inc.
K152644	KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100	Dec 31, 2015	Substantially Equivalent	Keeler Limited
K152308	Sensor Medical Single Use Tonometer Prism	Oct 13, 2015	Substantially Equivalent	Sensor Medical Technology, LLC
K142179	D-KAT Z-YPE	Sep 17, 2014	Substantially Equivalent	Keeler, Ltd.
K132549	ACCUTIP COVER	Apr 23, 2014	Substantially Equivalent	Accutome, Inc.
K133234	T-TYPE D-KAT, R-TYPE D-KAT	Feb 21, 2014	Substantially Equivalent	Keeler Limited
K132917	OCULAR FORCE GAUGE	Dec 20, 2013	Substantially Equivalent	Ocular Therapeutix, Inc.
K093445	KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT)	Jan 19, 2010	Substantially Equivalent	Keeler, Ltd.
K071755	FALCK APPLANATION TONOMETER (FAT2)	Jun 03, 2008	Substantially Equivalent	Falck Medical, Inc.
K063873	ICARE TONOMETER TA01I	May 23, 2007	Substantially Equivalent	Tiolat OY
K070534	MODIFICATION TO: OCU-FILM TIP COVER	Mar 27, 2007	Substantially Equivalent	Reichert, Inc.
K053430	TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER	Mar 03, 2006	Substantially Equivalent	Medtronic Xomed, Inc.
K033146	TONO-PEN TONOMETER TIP COVER	Nov 23, 2004	Substantially Equivalent	Tra & Accessories
K032967	PASCAL DYNAMIC CONTOUR TONOMETER	Nov 14, 2003	Substantially Equivalent	Smt Swiss Microtechnology AG
K032769	EYESOPEN TONOMETER	Sep 23, 2003	Substantially Equivalent	Eye-Deas, LLC
K023838	LUNEAU STERILE TONOMETER SEPARATION PRISMS	Feb 20, 2003	Substantially Equivalent	Luneau SA
K022054	F 900	Aug 06, 2002	Substantially Equivalent	C.S.O. S.R.L.
K011199	PROVIEW EYE PRESSURE MONITOR	Jul 02, 2001	Substantially Equivalent	Bausch & Lomb, Inc.
K992835	C.S.O. TONOMETER	Jun 06, 2000	Substantially Equivalent	Cso
K000288	REICHERT CT200 CONTACT TONOMETER	Mar 23, 2000	Substantially Equivalent	Reichert Ophthalmic Instruments, Div. Leica, Inc.
K991840	FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER	Mar 20, 2000	Substantially Equivalent	Bernard B. Fresco
K992998	AUTOMATED OPHTHALMICS SOFTIPS	Jan 10, 2000	Substantially Equivalent	Automated Ophthalmics, Inc.
K981432	GOLDMAN MANUAL TONOMETER	Jan 12, 1999	Substantially Equivalent	Golden Vision, Inc.
K970887	BLOOD FLOW ANALYZER	Jun 17, 1997	Substantially Equivalent	Paradigm Medical Industries, Inc.
K964312	MENTOR TONO-PEN 3	Nov 26, 1996	Substantially Equivalent	Mentor Ophthalmics, Inc.
K961512	PERKINS HAND-HELD APPLANATION TONOMETER	Jul 18, 1996	Substantially Equivalent	Clement Clarke, Inc.
K960924	KOWA HAND-HELD APPLANATION TONOMETER HA-1	Jun 04, 1996	Substantially Equivalent	Kowa Optimed, Inc.
K945446	BOBES TONOMETER	Jun 20, 1995	Substantially Equivalent	Bobes S.A.
K945541	SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE	May 08, 1995	Substantially Equivalent	Rudolf Riester GmbH & Co. KG
K924760	TOMEY PROTON TONOMETER	Apr 05, 1993	Substantially Equivalent	Tomey Corporation USA
K923877	TONOSHIELD TONOMETER SHIELD	Sep 30, 1992	Substantially Equivalent	Oasis Medical, Inc.
K882750	OCU-FILM TIP COVER	Aug 04, 1988	Substantially Equivalent	Oculab, Inc.
K860330	MAKLAKOV STYLE TONOMETER	Feb 12, 1986	Substantially Equivalent	Med-Tech Develoment Corp.
K852774	OCULAB TONOPEN	Aug 20, 1985	Substantially Equivalent	Oculab, Inc.
K834187	JAKOBI SURG. INSTRUMENTS #6 50	Mar 05, 1984	Substantially Equivalent	Imm Enterprises , Ltd.
K832996	SURGICAL IOP MONITOR	Nov 28, 1983	Substantially Equivalent	Miami Eye Technology, Inc.
K813619	CONPHAR-SCHIOETZ TONOMETER	Feb 24, 1982	Substantially Equivalent	Conphar, Inc.
K781105	TONOMETER, DIGITON	Sep 27, 1978	Substantially Equivalent	Ical, Inc.
K772130	OCULAR CEREBRAL VASCULAR MONITOR	Nov 28, 1977	Substantially Equivalent	Digilab, Inc.