QXJ
- 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.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242604 | 2025-05-27 | Preventamed Technologies, Inc. Dba Sur | Helios+ UV-C System | FDA |
Official FDA classification page: QXJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).