# K172474: Celerity 20 HP Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Dec 29, 2017 after 136 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: 6 generations back to K994055 (2002). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140708: Verify V24 Self-Contained Biological Indicator, STERIS Corporation (2014) Summary page 5.

## Indications for use
The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles: * Lumen, Non Lumen, and Flexible Cycles of the V-PRO® Low Temperature Sterilization Systems. * STERRAD® 100S Sterilizer (Default Cycle) » Standard and Advanced Cycles of the STERRAD® NX Sterilizer » Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX Sterilizer When used in conjunction with the Celerity HP Incubator, the Incubator for the Celerity 20 HP BI provides a fluorescent result within 20 minutes.

Source page: https://510kreport.com/device/K172474
Methodology: https://510kreport.com/methodology