FDA Product Code HKX: Tonometer, Ac-powered
Leading manufacturers include Bio-Rad, Company Elamed and Medimaging Integrated Solution, 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
Cleared
Nov 07, 2025
AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
Topcon Corporation
Ophthalmic
46d
Cleared
Nov 08, 2023
VS Tabletop Tonometer
Medimaging Integrated Solution, Inc.
Ophthalmic
329d
Cleared
Dec 06, 2019
Intraocular Pressure Tonometer EASYTON
Company Elamed
Ophthalmic
290d
Cleared
Jun 21, 2019
MiiS Horus Scope DPT 100
Medimaging Integrated Solution, Inc (Miis)
Ophthalmic
406d
Cleared
Feb 08, 2019
Keeler TonoCare Tonometer
Keeler Instruments, Inc.
Ophthalmic
283d
Cleared
Dec 14, 2018
Tono Vue Non-Contact Tonometer
Crystalvue Medical Corporation
Ophthalmic
260d
Cleared
Jun 22, 1993
TIP & MEMBRANE ASSEMBLY
Bio-Rad
Ophthalmic
483d
Cleared
Aug 05, 1992
CYLINDER OF GAS, CAN OF GAS (CC12F2)
Bio-Rad
Ophthalmic
121d
Cleared
Oct 31, 1989
BIO-RAD MODULAR AIR COMPRESSOR
Bio-Rad
Ophthalmic
47d
Cleared
Feb 20, 1987
DIGILAB MICRO ONE APPLANATION TONOMETER
Bio-Rad
Ophthalmic
39d
Cleared
Sep 24, 1986
DIGILAB MODULAR ONE-APPLANATION TONOMETER
Bio-Rad
Ophthalmic
35d
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 →