# K181429: CELERITY 20 HP Biological Indicator

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Jun 13, 2018 after 12 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: 8 generations back to K042450 (2005). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172752: CELERITY 20 HP Biological Indicator, STERIS Corporation (2018) Summary page 5.

## Indications for use
The CELERITY Biological Indicator is used for routine monitoring, and qualification of the Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Low Temperature Sterilizers in healthcare facilities. When used in conjunction with the VERIFY CELERITY 20 HP Incubator, the CELERITY 20 HP Biological Indicator provides a fluorescent result within 20 minutes.

Source page: https://510kreport.com/device/K181429
Methodology: https://510kreport.com/methodology