Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6510](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6510) → QXJ — Whole Room Microbial Reduction Device

# QXJ · Whole Room Microbial Reduction Device

_General Hospital · 21 CFR 880.6510 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/QXJ

## Overview

- **Product Code:** QXJ
- **Device Name:** Whole Room Microbial Reduction Device
- **Regulation:** [21 CFR 880.6510](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6510)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

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.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K242604](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/QXJ/K242604.md) | Helios+ UV-C System | Preventamed Technologies, Inc. Dba Surfacide Manufacturing | May 27, 2025 | SESE |
| [DEN230007](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/QXJ/DEN230007.md) | LightStrike+ (MXSUV1-SL and MXSUV1-FT) | Xenex Disinfection Services, Inc. | Sep 1, 2023 | DENG |

## Top Applicants

- Preventamed Technologies, Inc. Dba Surfacide Manufacturing — 1 clearance
- Xenex Disinfection Services, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/QXJ](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/QXJ)

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