FDA Product Code BSK: Cuff, Tracheal Tube, Inflatable
Leading manufacturers include Covidien, LLC, Aw Technologies Aps and Hospitech Respiration , Ltd..
FDA 510(k) Cleared Cuff, Tracheal Tube, Inflatable Devices (Product Code BSK)
About Product Code BSK - Regulatory Context
510(k) Submission Activity
39 total 510(k) submissions under product code BSK since 1979, with 39 receiving FDA clearance (average review time: 166 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under BSK have taken an average of 226 days to reach a decision - up from 162 days historically. Manufacturers should account for longer review timelines in current project planning.
BSK devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →