FDA Product Code HKI: Camera, Ophthalmic, Ac-powered
Leading manufacturers include Welch Allyn, Inc., Canon, Inc. and Verily Life Sciences, LLC.
FDA 510(k) Cleared Camera, Ophthalmic, Ac-powered Devices (Product Code HKI)
About Product Code HKI - Regulatory Context
510(k) Submission Activity
156 total 510(k) submissions under product code HKI since 1977, with 156 receiving FDA clearance (average review time: 122 days).
Submission volume has increased in recent years - 8 submissions in the last 24 months compared to 6 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for HKI submissions have been consistent, averaging 134 days recently vs 121 days historically.
HKI devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →