FDA Product Code CBI: Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
Leading manufacturers include Ambu A/S, Shenzhen Insighters Medical Technology Co., Ltd. and Hangzhou Tappa Medical Technology Co., Ltd..
FDA 510(k) Cleared Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) Devices (Product Code CBI)
About Product Code CBI - Regulatory Context
510(k) Submission Activity
34 total 510(k) submissions under product code CBI since 1985, with 34 receiving FDA clearance (average review time: 174 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under CBI have taken an average of 206 days to reach a decision - up from 172 days historically. Manufacturers should account for longer review timelines in current project planning.
CBI devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →