# K140515: Verify Hpu Chemical Indicator/ Verify Vaporized VH202 Process Indicator Adhesive Label

- Pathway: 510(k) (Abbreviated)
- Applicant: STERIS Corporation
- Decided: Jul 17, 2014 after 139 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: 3 generations back to K994055 (2002). 3 ancestors in all.
7 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)
- K091174: Verify V-Pro Chemical Indicator, Version 1A: Verify V-Pro Chemical Indicator; Version 2A: Adhesive Label, STERIS Corporation (2009) Summary page 4.

## Most influential descendants
- K172746: VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label (2018), 6 descendants of its own
- K183295: Celerity HP Chemical Indicator (CI) (2019), 5 descendants of its own
- K192020: Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label (2019), 4 descendants of its own
- 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

## Indications for use
The VERIFY® HPU Chemical Indicator is a Class I 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 or Flexible sterilization cycle of a V-PRO® Low Temperature Sterilization System. The VERIFY® Vaporized 7H20 Process Indicator Adhesive Label is a Class I vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible color change from magenta to yellow, when the pack has been exposed to the Lumen, Non-Lumen or Flexible sterilization cycle of a V-PRO® Low Temperature Sterilization System.

Source page: https://510kreport.com/device/K140515
Methodology: https://510kreport.com/methodology