K242604 is an FDA 510(k) clearance for the Helios+ UV-C System. This device is classified as a Whole Room Microbial Reduction Device (Class II - Special Controls, product code QXJ).
Submitted by Preventamed Technologies, Inc. Dba Surfacide Manufacturing (Waukesha, US). The FDA issued a Cleared decision on May 27, 2025, 270 days after receiving the submission on August 30, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 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..
| 510(k) Number | K242604 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2024 |
| Decision Date | May 27, 2025 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | QXJ - Whole Room Microbial Reduction Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6510 |
| 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. |