# K231488: Celerity™ HP Chemical Indicator;  Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape

- Pathway: 510(k) (Traditional)
- Applicant: Steris
- Decided: Aug 7, 2023 after 76 days
- Product code: JOJ (Indicator, Physical/Chemical 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 K921910 (1993). 16 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192020: Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label, STERIS Corporation (2019) Summary page 5.
- K213262: CELERITY HP Chemical Indicator, STERIS Corporation (2022) Summary page 8.
- K172746: VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label, STERIS Corporation (2018) Summary page 12.
- K183293: VERIFY VH202 Indicator Tape, STERIS Corporation (2019) Summary page 15.

## Most influential descendants
- 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 Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow or lighter, when the device has been exposed to the: • Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast or Specialty sterilization cycle of a V-PRO® Low Temperature Sterilization System, or • Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology. The Celerity™ HP Multivariable 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, Fast or Specialty sterilization cycle of a V-PRO Low Temperature Sterilization System, or • Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD System, including those systems with ALLClear Technology. The VERIFY® HPU Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units when placed within packs to be sterilized to indicate, through a visible change from magenta to yellow, when the device has been exposed to the Lumen, Non Lumen, Flexible, Fast Non Lumen, or Specialty sterilization cycle of a V-PRO® Low Temperature Sterilization System. The Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink) to peach, yellow or lighter. The Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches. The tape may be used in the following sterilization 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 Scope, Express and DUO Cycles of the STERRAD® 100NX Sterilizer without ALLClear.

Source page: https://510kreport.com/device/K231488
Methodology: https://510kreport.com/methodology