Cleared Traditional

K251354 - UV Smart D60 (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K251354 is an FDA 510(k) clearance for the UV Smart D60. Classified as Ultraviolet Radiation Disinfection Chamber Device (product code SCS), Class II - Special Controls.

Submitted by UV Smart Technologies B.V. (Rijswijk, NL). The FDA issued a Cleared decision on January 29, 2026 after a review of 274 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6511 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all UV Smart Technologies B.V. devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 128d · This submission: 274d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SCS Ultraviolet Radiation Disinfection Chamber Device
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - SCS Ultraviolet Radiation Disinfection Chamber Device

Devices cleared under the same product code (SCS) and FDA review panel - the closest regulatory comparables to K251354.
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