De Novo · Granted
GrantedVerify Cronos Self-Contained Biological Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · OWP Biological Sterilization Process Indicator With Recombinant-Dna Plasmid
Granted on Jul 12, 2013 as a new device type through De Novo after a 675-day review. 3 later devices descend from it.
- Decided
- Jul 12, 2013
- Review
- 675 days
- Class
- Class II
- Product code
- OWP
- Recalls
- None
3 later devices descend from it, 2 citing it directly.
- This deviceDEN110006 Verify Cronos Self-Contained Biological IndicatorSTERIS Corporation · 2013
- Descendant · cites it directly · 1 of its ownK162701 VERIFY Assert Self-Contained Biological IndicatorSTERIS Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK181442 VERIFY Assert Self-Contained Biological IndicatorSTERIS Corporation · 2018
- Descendant · cites it directly · 0 of its ownK163587 VERIFY Incubator for Assert Self Contained Biological IndicatorsSTERIS Corporation · 2017
Most influential descendants
Showing 3 of 3 · See all- K162701VERIFY Assert Self-Contained Biological IndicatorSTERIS Corporation · 2017 · cites it directly1descendant
- K181442VERIFY Assert Self-Contained Biological IndicatorSTERIS Corporation · 2018 · 2 generations on0descendants
- K163587VERIFY Incubator for Assert Self Contained Biological IndicatorsSTERIS Corporation · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN110006 | Verify Cronos Self-Contained Biological Indicator | STERIS Corporation | 2013 | — |
| +1 | K162701 | VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation | 2017 | — |
| +2 | K181442 | VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation | 2018 | — |
| +1 | K163587 | VERIFY Incubator for Assert Self Contained Biological Indicators | STERIS Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K162701 (STERIS Corporation, 2017) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OWP devicesOWP Biological Sterilization Process Indicator With Recombinant-Dna Plasmid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OWP
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · OWP
177in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWP
No recall names OWP since 2007.
Adverse event reports per year · OWP
2in 2022
MAUDE reports naming product code OWP, 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 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 3 | 177 | 0 | 1 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN110006 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN110006: Verify Cronos Self-Contained Biological Indicator.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN110006
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026