FDA Product Code QXQ: Respiratory Accessory Microbial Reduction Device.
A Respiratory Accessory Microbial Reduction Device Is A Home-use Device Intended To Be Used As An Adjunct For Microbial Reduction Of Compatible Respiratory Accessories,such As Hoses And Masks,after Cleaning. This Device Is Not Intended To Replace The Original Accessory Manufacturers Cleaning Instructions.
Leading manufacturers include Soclean, Inc. and LiViliti Health Products Corporation.
3
Total
2
Cleared
544d
Avg days
2024
Since
Growing category -
2 submissions in the last 2 years
vs 1 in the prior period
Review times improving: avg
285d
recently vs 1062d historically
FDA 510(k) Cleared Respiratory Accessory Microbial Reduction Device. Devices (Product Code QXQ)
3 devices
Cleared
Apr 29, 2026
Paptizer 360
LiViliti Health Products Corporation
General Hospital
266d
Cleared
Oct 10, 2025
SoClean 3+
Soclean, Inc.
General Hospital
303d
Not Cleared
Aug 12, 2024
SoClean 3+ Bacterial Reduction Device
Soclean, Inc.
General Hospital
1062d
About Product Code QXQ - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QXQ since 2024, with 2 receiving FDA clearance (average review time: 544 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 510(k) Review Time - QXQ Product Code
Recent submissions under QXQ have taken an average of 285 days to reach a decision - down from 1062 days historically, suggesting improved FDA processing for this classification.
QXQ devices are reviewed by the General Hospital panel. Browse all General Hospital devices →