# K163587: VERIFY Incubator for Assert Self Contained Biological Indicators

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Mar 24, 2017 after 94 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
Longest line of descent: 1 generation back to DEN110006 (2013). 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)
- DEN110006: Verify Cronos Self-Contained Biological Indicator, STERIS Corporation (2013). Our reading of the summary gave K102469, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN110006, Verify Cronos Self-Contained Biological Indicator (STERIS Corporation), granted Jul 12, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant. Summary page 5.

## Indications for use
Use the VERIFY® Incubator for Assert™ Self Contained Biological Indicators SCBI (Incubator) to incubate and automatically read VERIFY Assert Self-Contained Biological Indicators at 57 °C for a fluorescent result within 40 minutes.

Source page: https://510kreport.com/device/K163587
Methodology: https://510kreport.com/methodology