# K223717: Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Jun 15, 2023 after 185 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: 9 generations back to K042450 (2005). 14 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183294: CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack, STERIS Corporation (2019) Summary page 5.
- K173488: CELERITY 20 HP Challenge Pack, STERIS Corporation (2018) Summary page 8.

## Most influential descendants
- K250044: Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) (2025), 1 descendant of its own
- K260766: Celerity 5 HP Biological Indicator (LCB052) (2026), 0 descendants of its own
- K251452: Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) (2025), 0 descendants of its own

## Indications for use
Celerity 5 HP Biological Indicator The Celerity 5 HP Biological Indicator (BI) is used for 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, 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®. When used in conjunction with the Celerity® Incubator, the Incubator provides a fluorescent result within 5 minutes. Celerity 5 HP Challenge Pack The Celerity 5 HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing. The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included. The Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

Source page: https://510kreport.com/device/K223717
Methodology: https://510kreport.com/methodology