FDA Product Code BTR: Tube, Tracheal (w/wo Connector)
FDA product code BTR covers tracheal tubes used to maintain an open airway during anesthesia, mechanical ventilation, and emergency airway management.
These tubes are inserted through the mouth or nose into the trachea to provide a secure, controlled airway that prevents aspiration and enables mechanical ventilation. They are available with or without inflatable cuffs, in a range of sizes for adults and children.
BTR devices are Class II medical devices, regulated under 21 CFR 868.5730 and reviewed by the FDA Anesthesiology panel.
Leading manufacturers include Covidien, LLC, Covidien and Teleflex Incorporated.
FDA 510(k) Cleared Tube, Tracheal (w/wo Connector) Devices (Product Code BTR)
About Product Code BTR - Regulatory Context
510(k) Submission Activity
240 total 510(k) submissions under product code BTR since 1976, with 240 receiving FDA clearance (average review time: 128 days).
Submission volume has increased in recent years - 8 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under BTR have taken an average of 213 days to reach a decision - up from 125 days historically. Manufacturers should account for longer review timelines in current project planning.
BTR devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →