FDA Product Code CBF: Chamber, Hyperbaric
Leading manufacturers include Us Hyperbaric Network and Fink Engineering Pty, Ltd..
FDA 510(k) Cleared Chamber, Hyperbaric Devices (Product Code CBF)
About Product Code CBF - Regulatory Context
510(k) Submission Activity
69 total 510(k) submissions under product code CBF since 1979, with 69 receiving FDA clearance (average review time: 207 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under CBF have taken an average of 266 days to reach a decision - up from 206 days historically. Manufacturers should account for longer review timelines in current project planning.
CBF devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →