FDA Product Code NFB: Conserver, Oxygen
Leading manufacturers include Responsive Respiratory.
FDA 510(k) Cleared Conserver, Oxygen Devices (Product Code NFB)
About Product Code NFB - Regulatory Context
510(k) Submission Activity
71 total 510(k) submissions under product code NFB since 1983, with 71 receiving FDA clearance (average review time: 116 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 NFB have taken an average of 170 days to reach a decision - up from 116 days historically. Manufacturers should account for longer review timelines in current project planning.
NFB devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →