HKY · Class II · 21 CFR 886.1930

FDA Product Code HKY: Tonometer, Manual

Leading manufacturers include Icare Finland OY, Cats Tonometer, LLC and Keeler Limited.

Total

Cleared

134d

Avg days

1977

Since

Declining activity - 0 submissions in the last 2 years vs 5 in the prior period

FDA 510(k) Cleared Tonometer, Manual Devices (Product Code HKY)

56 devices

1–24 of 56

Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)

CATS-L Tonometer™ Prism

Applanation Tonometer HT-5000

CATS®-D Tonometer Prism

Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q

K191314

Chongqing Sunkingdom Medical Instrument Co., Ltd.

Ophthalmic · 218d

Cleared Dec 10, 2018

Applanation tonometer AT-2

K182491

Takagi Seiko Co., Ltd.

Carl Zeiss Meditec, AG

Applanation tonometer AT-1

K172728

Takagi Seiko Co., Ltd.

Applanation Tonometer

K142263

Shanghai Mediworks Precision Instruments Co. , Ltd.

Ophthalmic · 610d

Cleared Jan 15, 2016

Falck Medical Multifunction Tonometer, FAT1

KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100

Sensor Medical Single Use Tonometer Prism

K152308

Sensor Medical Technology, LLC

T-TYPE D-KAT, R-TYPE D-KAT

Ocular Therapeutix, Inc.

Ophthalmic · 94d

About Product Code HKY - Regulatory Context

510(k) Submission Activity

56 total 510(k) submissions under product code HKY since 1977, with 56 receiving FDA clearance (average review time: 134 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 5 in the prior period.

FDA Product Code HKY: Tonometer, Manual

FDA 510(k) Cleared Tonometer, Manual Devices (Product Code HKY)

About Product Code HKY - Regulatory Context

510(k) Submission Activity

Related FDA 510(k) Regulatory Insights