FDA Product Code BSO: Catheter, Conduction, Anesthetic
Leading manufacturers include Teleflex Medical, B.Braun Medical, Inc. and Jmt Co., Ltd..
FDA 510(k) Cleared Catheter, Conduction, Anesthetic Devices (Product Code BSO)
About Product Code BSO - Regulatory Context
510(k) Submission Activity
75 total 510(k) submissions under product code BSO since 1980, with 75 receiving FDA clearance (average review time: 162 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under BSO have taken an average of 272 days to reach a decision - up from 161 days historically. Manufacturers should account for longer review timelines in current project planning.
BSO devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →