De Novo · Granted
GrantedChronos®
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Germitec · SCS Ultraviolet Radiation Disinfection Chamber Device
Granted on Aug 28, 2024 as a new device type through De Novo after a 335-day review. 1 later device descends from it.
- Decided
- Aug 28, 2024
- Review
- 335 days
- Class
- Class II
- Product code
- SCS
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN230067 Chronos®Germitec · 2024
- Descendant · cites it directly · 0 of its ownK251354 UV Smart D60UV Smart Technologies B.V. · 2026
Most influential descendants
Showing 1 of 1 · See all- K251354UV Smart D60UV Smart Technologies B.V. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN230067 | Chronos® | Germitec | 2024 | — |
| +1 | K251354 | UV Smart D60 | UV Smart Technologies B.V. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SCS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new SCS device
- #1 K251354 UV Smart D60score 10.8 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251354 | UV Smart D60 | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K251354 (UV Smart Technologies B.V., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All SCS devicesSCS Ultraviolet Radiation Disinfection Chamber Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SCS
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · SCS
Too few SCS 510(k)s in any year since 2007 to give a median.
Recalls per year · SCS
No recall names SCS since 2007.
Adverse event reports per year · SCS
1in 2025
MAUDE reports naming product code SCS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN230067 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN230067: Chronos®.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN230067
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026