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QXQ — Respiratory Accessory Microbial Reduction Device. Class II

FDA Device Classification

Classification Details

Product Code
QXQ
Device Class
Class II
Regulation Number
880.6993
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Definition

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 manufacturer’s cleaning instructions.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243815socleanSoClean 3+October 10, 2025
DEN210037socleanSoClean 3+ Bacterial Reduction DeviceAugust 12, 2024