K251354 is an FDA 510(k) clearance for the UV Smart D60. This device is classified as a Ultraviolet Radiation Disinfection Chamber Device (Class II - Special Controls, product code SCS).
Submitted by UV Smart Technologies B.V. (Rijswijk, NL). The FDA issued a Cleared decision on January 29, 2026, 274 days after receiving the submission on April 30, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6511. An Ultraviolet Radiation Disinfection Chamber Device Is Intended To Disinfect Patient Contacting Medical Devices Using Uv Radiation After The Device Has Been Cleaned. Disinfection Of The Medical Device Is Achieved Within An Enclosed Chamber Through The Exposure To Uv Radiation..
| 510(k) Number | K251354 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2025 |
| Decision Date | January 29, 2026 |
| Days to Decision | 274 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | SCS - Ultraviolet Radiation Disinfection Chamber Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6511 |
| Definition | An Ultraviolet Radiation Disinfection Chamber Device Is Intended To Disinfect Patient Contacting Medical Devices Using Uv Radiation After The Device Has Been Cleaned. Disinfection Of The Medical Device Is Achieved Within An Enclosed Chamber Through The Exposure To Uv Radiation. |