DeviceClearance

Product code QXJ— General Hospital

Helios+ UV-C System

Classification name
Whole Room Microbial Reduction Device
Device class
Class 2
Regulation
21 CFR 880.6510
Advisory panel
General Hospital
Total cleared
2
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QXJ under 21 CFR 880.6510, via openFDA

Market context for product code QXJ

FDA has cleared 2 devices under product code QXJ between 2023 and 2025, 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 QXJ

Recent clearances under product code QXJ

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