FDA Product Code BTO: Tube, Tracheostomy (w/wo Connector)
Leading manufacturers include Teleflex Medical and Vitaltec Corporation.
FDA 510(k) Cleared Tube, Tracheostomy (w/wo Connector) Devices (Product Code BTO)
About Product Code BTO - Regulatory Context
510(k) Submission Activity
128 total 510(k) submissions under product code BTO since 1976, with 128 receiving FDA clearance (average review time: 107 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 BTO have taken an average of 259 days to reach a decision - up from 106 days historically. Manufacturers should account for longer review timelines in current project planning.
BTO devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →