# K091174: Verify V-Pro Chemical Indicator, Version 1A: Verify V-Pro Chemical Indicator; Version 2A: Adhesive Label

- Pathway: 510(k) (Abbreviated)
- Applicant: STERIS Corporation
- Decided: Oct 27, 2009 after 188 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: 2 generations back to K994055 (2002). 2 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072510: Verify V-Pro Chemical Indicator, Versions 1 and 2, STERIS Corporation (2007) Summary page 2.

## Most influential descendants
- K140515: Verify Hpu Chemical Indicator/ Verify Vaporized VH202 Process Indicator Adhesive Label (2014), 7 descendants of its own
- 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

## Indications for use
The Verify® V-PRO Chemical Indicator (Version 1A) and the Verify® V-PRO Chemical Indicator Adhesive Label (Version 2A) are Class 1 vaporized hydrogen peroxide sterilization process indicators that conform to ANSI/AAMI/ISO 11140-1: 2005. They are designed to distinguish between processed and unprocessed units when placed within (Version 1A) or affixed to (Version 2A) sterilization wraps, trays or pouches to indicate, through a visible change from magenta to yellow, when the device (Version 1A) or pack (Version 2A) has been exposed to a V-PRO 1 Low Temperature sterilization process (Lumen Cycle) or V-PRO 1 Plus Low Temperature sterilization process (Lumen or Non-Lumen cycle). This product is designed for use exclusively in the Amsco V-PRO 1 Low Temperature Sterilization System and Amsco V-PRO 1 Plus Low Temperature Sterilization System at 50 °C using Vaprox TM HC Sterilant. The Verify® V-PRO Chemical Indicator (Version 1A) and the Verify® V-PRO Chemical Indicator Adhesive Label (Version 2A) intended for use in vaporized hydrogen peroxide sterilization processes. The Verify® V-PRO Chemical Indicator (Version IA) and the Verify® V-PRO Chemical Indicator Adhesive Label (Version 2A) change color from magenta to yellow when exposed to the appropriate cycle conditions of temperature, sterilant concentration and duration, as shown in the table below: Model | Temperature | Sterilant Concentration | Cycle Type | Exposure Time Verify Version 1A | 50 °C | 2.1 g H 2 02 x 4 injections | Lumen | 32 minutes Verify Version 2A | 50 °C | 2.1 g H 2 0 2 x 4 injections | Lumen | 32 minutes Verify Version 1A | 50 °C | 2.1 g H2 0 2 x 4 injections | Non-Lumen | 12 minutes Verify Version 2A | 50 °C | 2.1 g H 20 2 x 4 injections | Non-Lumen | 12 minutes

Source page: https://510kreport.com/device/K091174
Methodology: https://510kreport.com/methodology