FDA Product Code HKX: Tonometer, Ac-powered
Leading manufacturers include Topcon Corporation.
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
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 Review Time
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 →