# DEN110006: Verify Cronos Self-Contained Biological Indicator

- Pathway: De Novo (Post-NSE)
- Applicant: STERIS Corporation
- Decided: Jul 12, 2013 after 675 days
- Product code: OWP (Biological Sterilization Process Indicator With Recombinant-Dna Plasmid)
- Device class: 2
- Regulation: 21 CFR 880.2805
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K162701: VERIFY Assert Self-Contained Biological Indicator (2017), 1 descendant of its own
- K181442: VERIFY Assert Self-Contained Biological Indicator (2018), 0 descendants of its own
- K163587: VERIFY Incubator for Assert Self Contained Biological Indicators (2017), 0 descendants of its own

Source page: https://510kreport.com/device/DEN110006
Methodology: https://510kreport.com/methodology