FDA Product Code NHJ: Device, Positive Pressure Breathing, Intermittent

FDA 510(k) Cleared Device, Positive Pressure Breathing, Intermittent Devices (Product Code NHJ)

About Product Code NHJ - Regulatory Context

510(k) Submission Activity

25 total 510(k) submissions under product code NHJ since 1978, with 25 receiving FDA clearance (average review time: 187 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - NHJ Product Code

Recent submissions under NHJ have taken an average of 272 days to reach a decision - up from 179 days historically. Manufacturers should account for longer review timelines in current project planning.

NHJ devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →

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