# K252680: Celerity™ 20 HP Biological Indicator

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Sep 24, 2025 after 30 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: 10 generations back to K042450 (2005). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231490: Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator, STERIS Corporation (2023) Summary page 6.

## Indications for use
The Celerity™ 20 HP Biological Indicator (Bl) is intended for routine monitoring of the following sterilizer cycles: • Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems. • STERRAD® 100S Sterilizer (Default Cycle) • Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear • Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear® Technology When used in conjunction with the Celerity™ HP Incubator or the Celerity™ Incubator, the Celerity™ 20 HP Bl provides a fluorescent result within 20 minutes.

Source page: https://510kreport.com/device/K252680
Methodology: https://510kreport.com/methodology