FDA Product Code NHJ: Device, Positive Pressure Breathing, Intermittent
Leading manufacturers include Abmrc, LLC and Breas Medical AB.
FDA 510(k) Cleared Device, Positive Pressure Breathing, Intermittent Devices (Product Code NHJ)
About Product Code NHJ - Regulatory Context
510(k) Submission Activity
24 total 510(k) submissions under product code NHJ since 1978, with 24 receiving FDA clearance (average review time: 183 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under NHJ have taken an average of 273 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 →