FDA Product Code BTL: Ventilator, Emergency, Powered (resuscitator)
Leading manufacturers include Vortran Medical Technology 1, Inc., Magnamed Tecnologia Medica S/A and Draegerwerk AG & CO Kgaa.
FDA 510(k) Cleared Ventilator, Emergency, Powered (resuscitator) Devices (Product Code BTL)
About Product Code BTL - Regulatory Context
510(k) Submission Activity
100 total 510(k) submissions under product code BTL since 1977, with 100 receiving FDA clearance (average review time: 156 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 BTL have taken an average of 203 days to reach a decision - up from 156 days historically. Manufacturers should account for longer review timelines in current project planning.
BTL devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →