HKY · Class II · 21 CFR 886.1930

FDA Product Code HKY: Tonometer, Manual

Leading manufacturers include Icare Finland OY, Cats Tonometer, LLC and Carl Zeiss Meditec, AG.

Total

Cleared

134d

Avg days

1977

Since

Declining activity - 1 submissions in the last 2 years vs 4 in the prior period

Consistent review times: 128d avg (recent)

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

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 - 1 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - HKY Product Code

FDA review times for HKY submissions have been consistent, averaging 128 days recently vs 134 days historically.

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

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

FDA 510(k) Review Time - HKY Product Code

Related FDA 510(k) Regulatory Insights