FDA Product Code IRT: Pad, Heating, Powered

FDA 510(k) Cleared Pad, Heating, Powered Devices (Product Code IRT)

About Product Code IRT - Regulatory Context

510(k) Submission Activity

42 total 510(k) submissions under product code IRT since 1977, with 42 receiving FDA clearance (average review time: 177 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - IRT Product Code

Recent submissions under IRT have taken an average of 245 days to reach a decision - up from 175 days historically. Manufacturers should account for longer review timelines in current project planning.

IRT devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →

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