Product code QXQ— General Hospital

Paptizer 360

Classification name
Respiratory Accessory Microbial Reduction Device.
Device class
Class 2
Regulation
21 CFR 880.6993
Advisory panel
General Hospital
Total cleared
3
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QXQ under 21 CFR 880.6993, via openFDA

Market context for product code QXQ

FDA has cleared 3 devices under product code QXQ between 2024 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QXQ

Recent clearances under product code QXQ

Data sourced from openFDA. This site is unofficial and independent of the FDA.