# K260766: Celerity 5 HP Biological Indicator (LCB052)

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Apr 8, 2026 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). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223717: Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack, STERIS Corporation (2023) Summary page 6.

## Indications for use
The Celerity 5 HP Biological indicator is intended for the routine monitoring of the following sterilizer cycles: • Lumen, Non Lumen, Fast Non Lumen, Fast and Flexible Cycles of the V-PRO: 1, 1 Plus, maX, maX2 and s2 Low Temperature Sterilization Systems • STERRAD® lO0S Sterilizer (Default Cycle) • Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear Technology • Standard, Flex Scope, Express, and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear Technology When used in conjunction with the Celerity HP Incubator, the Celerity HP BI provides a fluorescent result within 5 minutes.

Source page: https://510kreport.com/device/K260766
Methodology: https://510kreport.com/methodology