FDA Product Code QBP: Cap, Device Disinfectant
Disinfect Needleless Access Valves And May Act As A Physical Barrier To Contamination If Not Removed For A Set Period Of Time
Leading manufacturers include Icu Medical, Inc., Cleansite Medical, Inc. and 1World Vista Medical.
FDA 510(k) Cleared Cap, Device Disinfectant Devices (Product Code QBP)
About Product Code QBP - Regulatory Context
510(k) Submission Activity
22 total 510(k) submissions under product code QBP since 2008, with 22 receiving FDA clearance (average review time: 203 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QBP have taken an average of 269 days to reach a decision - up from 196 days historically. Manufacturers should account for longer review timelines in current project planning.
QBP devices are reviewed by the General Hospital panel. Browse all General Hospital devices →