# K173629: CELERITY 20 Steam Process Challenge Device for Gravity Cycles

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Feb 21, 2018 after 89 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: 5 generations back to K926364 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170070: VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles, STERIS Corporation (2017) Summary page 5.

## Indications for use
The Celerity 20 Steam Challenge Pack is used for qualification, routine microbial monitoring, and load monitoring of steam sterilizers. The validated steam sterilization cycles include: 250°F (121°C) 30-minute gravity 270°F (132°C) 15-minute gravity

Source page: https://510kreport.com/device/K173629
Methodology: https://510kreport.com/methodology