# K251354: UV Smart D60

- Pathway: 510(k) (Traditional)
- Applicant: UV Smart Technologies B.V.
- Decided: Jan 29, 2026 after 274 days
- Product code: SCS (Ultraviolet Radiation Disinfection Chamber Device)
- Device class: 2
- Regulation: 21 CFR 880.6511
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN230067 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230067: Chronos®, Germitec (2024) Summary page 5.

## Indications for use
The UV Smart D60 is indicated for use in a healthcare environment to achieve a high level disinfection (HLD) of external surfaces of Transesophageal Echocardiogram (TEE) probes that do not contain lumens and that do not contain indentations or channels that are deeper than their widths.

Source page: https://510kreport.com/device/K251354
Methodology: https://510kreport.com/methodology