FDA Product Code QXJ: Whole Room Microbial Reduction Device
A Whole Room Microbial Reduction Device Is A Medical Device To Be Used To Reduce Microbial Load On Medical Device Surfaces Following Cleaning And Disinfection.
Leading manufacturers include Xenex Disinfection Services, Inc. and Preventamed Technologies, Inc. Dba Surfacide Manufacturing.
FDA 510(k) Cleared Whole Room Microbial Reduction Device Devices (Product Code QXJ)
About Product Code QXJ - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QXJ since 2023, with 1 receiving FDA clearance (average review time: 241 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under QXJ have taken an average of 270 days to reach a decision - up from 212 days historically. Manufacturers should account for longer review timelines in current project planning.
QXJ devices are reviewed by the General Hospital panel. Browse all General Hospital devices →