FDA Product Code HBC: Motor, Drill, Electric

FDA 510(k) Cleared Motor, Drill, Electric Devices (Product Code HBC)

About Product Code HBC - Regulatory Context

510(k) Submission Activity

26 total 510(k) submissions under product code HBC since 1981, with 26 receiving FDA clearance (average review time: 146 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 - HBC Product Code

Recent submissions under HBC have taken an average of 361 days to reach a decision - up from 128 days historically. Manufacturers should account for longer review timelines in current project planning.

HBC devices are reviewed by the Neurology panel. Browse all Neurology devices →

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