QXJClass II

Whole Room Microbial Reduction Device

General Hospital · 21 CFR 880.6510

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.

MDR events1All time

Recalls1All time

Registered firms2Currently listed

510(k) clearances2All time

Recent MDR events

1 adverse event reports on file

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OHMNICLEAN UV-C DISINFECTION ROBOTDec 9, 2025
InjuryOhmnilabs, Inc.MW5180182

Event type breakdown

Injury1

Most-reported manufacturers

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Ohmnilabs, Inc.1

Recalls

1 recall events for this product code

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XENEX Disinfection Services Inc.
Open, ClassifiedApr 23, 2024
LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used with the LightStrike Germ-Zapping Robots Models: PX
Blackout curtains are no longer recommended as a protective barrier against UV/Ozone exposure to a bystander standing in the same room, but on the other side of the curtain from where a microbial reduction device UV cycle is taking place. Bystanders in the room during the cycle may experience temporary skin reddening, feeling of sand in eyes, nausea, headache, and/or mucous membrane irritation.
Z-1615-2024 · View FDA record ↗

Registered firms

2 firms currently registered for this product code

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510(k) clearances

2 clearances for this product code

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