Cleared Traditional

UV Smart D60

K251354 · UV Smart Technologies B.V. · General Hospital
Jan 2026
Decision
274d
Days
Class 2
Risk

About This 510(k) Submission

K251354 is an FDA 510(k) clearance for the UV Smart D60, 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 review panel. Regulated under 21 CFR 880.6511.

Submission Details

510(k) Number K251354 FDA.gov
FDA Decision Cleared 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

Device Classification

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.