FDA Product Code MPA: Endoilluminator

FDA 510(k) Cleared Endoilluminator Devices (Product Code MPA)

About Product Code MPA - Regulatory Context

510(k) Submission Activity

40 total 510(k) submissions under product code MPA since 1995, with 40 receiving FDA clearance (average review time: 128 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MPA Product Code

Recent submissions under MPA have taken an average of 199 days to reach a decision - up from 125 days historically. Manufacturers should account for longer review timelines in current project planning.

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

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