# K213262: CELERITY HP Chemical Indicator

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Jan 7, 2022 after 99 days
- Product code: QKM (A Chemical Vapor Sterilization Multivariable Chemical Indicator)
- 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: 7 generations back to K921910 (1993). 7 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203284: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator, 3M Company (2020) Summary page 5.

## Most influential descendants
- K231488: Celerity™ HP Chemical Indicator;  Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape (2023), 2 descendants of its own
- K240760: CELERITY HP Indicator Tape (2024), 1 descendant of its own
- K242189: CELERITY HP Indicator Tape (PCC077) (2024), 0 descendants of its own

## Indications for use
The Celerity™ HP Chemical Indicator is a vaporized hydrogen peroxide multivariable chemical indicator. It is designed for routine monitoring of the following cycles: * Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or » Standard, Advanced, Express, Flex or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.

Source page: https://510kreport.com/device/K213262
Methodology: https://510kreport.com/methodology