# K173670: CELERITY 20 Steam Incubator

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Feb 12, 2018 after 74 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: 3 generations back to K004009 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171587: VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator, STERIS Corporation (2017) Summary page 5.

## Indications for use
Use the Celerity 20 Steam Incubator to incubate and automatically read Celerity 20 Steam Biological Indicators at 57 °C for a fluorescent result within 20 minutes

Source page: https://510kreport.com/device/K173670
Methodology: https://510kreport.com/methodology