HKX · Class II · 21 CFR 886.1930

FDA Product Code HKX: Tonometer, Ac-powered

Leading manufacturers include Bio-Rad, Keeler Instruments, Inc. and Nidek, Inc..

58
Total
58
Cleared
146d
Avg days
1980
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 46d recently vs 148d historically

FDA 510(k) Cleared Tonometer, Ac-powered Devices (Product Code HKX)

58 devices
1–24 of 58
Cleared Nov 07, 2025
AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
K253039
Topcon Corporation
Ophthalmic · 46d
Cleared Nov 08, 2023
VS Tabletop Tonometer
K223739
Medimaging Integrated Solution, Inc.
Ophthalmic · 329d
Cleared Dec 06, 2019
Intraocular Pressure Tonometer EASYTON
K190382
Company Elamed
Ophthalmic · 290d
Cleared Jun 21, 2019
MiiS Horus Scope DPT 100
K181260
Medimaging Integrated Solution, Inc (Miis)
Ophthalmic · 406d
Cleared Feb 08, 2019
Keeler TonoCare Tonometer
K181143
Keeler Instruments, Inc.
Ophthalmic · 283d
Cleared Dec 14, 2018
Tono Vue Non-Contact Tonometer
K180820
Crystalvue Medical Corporation
Ophthalmic · 260d
Cleared Apr 24, 2017
VX130 Ophthalmic Diagnostic Device
K162067
Luneau Sas
Ophthalmic · 272d
Cleared Jun 01, 2015
VX120 Ophthalmic Diagnostic Device
K143086
Luneau Sas
Ophthalmic · 217d
Cleared Nov 08, 2012
CORVIS ST
K113066
Oculus Optikgerate GmbH
Ophthalmic · 388d
Cleared Sep 20, 2011
FULL AUTO TONOMETER MODEL TX-20
K111710
Canon Inc. -Medical Equipment Group
Ophthalmic · 92d
Cleared Dec 10, 2010
PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000
K093298
Keeler Instruments, Inc.
Ophthalmic · 415d
Cleared Jul 27, 2009
ACCUPEN
K083377
Accutome Ultrasound, Inc.
Ophthalmic · 255d
Cleared Nov 18, 2008
NON-CONTACT TONOMETER, MODEL FT-1000
K073087
Tomey Corporation
Ophthalmic · 383d
Cleared Aug 07, 2008
OCULAR RESPONSE ANALYZER
K081756
Reichert, Inc.
Ophthalmic · 48d
Cleared Jun 09, 2006
KOWA KT-800
K053444
Kowa Co. , Ltd.
Ophthalmic · 182d
Cleared Apr 06, 2006
TONOMETER DIATON
K060780
Ryazan State Instruments
Ophthalmic · 15d
Cleared Dec 10, 2004
TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)
K042099
Retinapharma Technologies, Inc.
Ophthalmic · 128d
Cleared Jan 20, 2004
NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER
K032799
Reichert, Inc.
Ophthalmic · 133d
Cleared Dec 04, 2003
NON-CONTACT TONOMETER, MODEL NT-4000
K031733
Nidek, Inc.
Ophthalmic · 183d
Cleared Apr 24, 2003
APPLANATION TONOMETER
K023676
Optilasa, S.L.
Ophthalmic · 174d
Cleared Nov 26, 2002
CANON FULL AUTO TONOMETER TX-F
K023816
Canon, Inc.-Utsunomiya Optical Products Operation
Ophthalmic · 11d
Cleared Oct 11, 2002
KOWA AUTOMATED TONOMETER KT-500
K013805
Kowa Optimed, Inc.
Ophthalmic · 330d
Cleared Oct 11, 2002
TGDC-01 PRA
K021937
Truevision Instruments
Ophthalmic · 121d
Cleared Feb 20, 2002
PORTABLE NON-CONTACT TONOMETER, MODEL PT100
K013259
Leica Microsystems, Inc. O.I.D.
Ophthalmic · 142d

About Product Code HKX - Regulatory Context

510(k) Submission Activity

58 total 510(k) submissions under product code HKX since 1980, with 58 receiving FDA clearance (average review time: 146 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - HKX Product Code

Recent submissions under HKX have taken an average of 46 days to reach a decision - down from 148 days historically, suggesting improved FDA processing for this classification.

HKX devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →