# K171587: VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Aug 22, 2017 after 83 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K004009 (2002). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123546: 3M Attest (TM) Auto-Reader, 3M Company (2013) Summary page 5.

## Most influential descendants
- K190297: Celerity HP Incubator (2019), 4 descendants of its own
- K213881: Celerity Incubator (2022), 3 descendants of its own
- K223715: Celerity Incubator (2023), 2 descendants of its own
- K250061: Celerity Incubator (2025), 0 descendants of its own
- K233681: ConFirm 20 Minute Incubator (2023), 0 descendants of its own

## Indications for use
Use the VERIFY Incubator for Assert VH2O2 Self Contained Biological Indicators (Incubator) to incubate and automatically read VERIFY Assert VH2O2 Self-Contained Biological Indicators at 57 °C for a fluorescent result within 20 minutes.

Source page: https://510kreport.com/device/K171587
Methodology: https://510kreport.com/methodology