# DEN230067: Chronos®

- Pathway: De Novo (Direct)
- Applicant: Germitec
- Decided: Aug 28, 2024 after 335 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K251354: UV Smart D60 (2026), 0 descendants of its own

## Indications for use
Chronos is indicated for use in a healthcare environment to achieve a high-level disinfection of surfaces of external, transvaginal, and transrectal ultrasound 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/DEN230067
Methodology: https://510kreport.com/methodology