FDA Product Code HKY: Tonometer, Manual
Leading manufacturers include Huvitz Co., Ltd., Reichert, Inc. and Cats Tonometer, LLC.
56
Total
56
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
Cleared
Sep 27, 2024
iCare ST500 (TA04)
Icare Finland OY
Ophthalmic
128d
Cleared
May 01, 2024
Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)
Reichert, Inc.
Ophthalmic
182d
Cleared
Feb 09, 2024
CATS-L Tonometer™ Prism
Cats Tonometer, LLC
Ophthalmic
50d
Cleared
Oct 23, 2023
Applanation Tonometer HT-5000
Huvitz Co., Ltd.
Ophthalmic
96d
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 Review Time
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 →