QXJ

Whole Room Microbial Reduction Device

Product code
QXJ
Device name
Whole Room Microbial Reduction Device
Device class
Class 2
21 CFR
21 CFR 880.6510
Medical specialty
General Hospital
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
0 (direct download)
510(k) clearances (all years, FDA)
2 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-05-27.

NumberDecision dateApplicantDevice nameSummary
K2426042025-05-27Preventamed Technologies, Inc. Dba SurHelios+ UV-C SystemFDA
Official FDA classification page: QXJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).