# K222508: 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Nov 1, 2022 after 75 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: 7 generations back to K921910 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203458: 3M Comply Hydrogen Peroxide Chemical Indicator 1248, 3M Company (2020) Summary page 5.

## Indications for use
Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in the following sterilizers and cycles: STERRAD 100® Sterilization System STERRAD 100S® Sterilization System STERRAD NX® Sterilization System (Standard and Advanced cycles) STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles) STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles) STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles) V-PRO® 1 Low Temperature Sterilization System (Lumen cycle) V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles) V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cycles) V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles) STERIZONE® VP4 Sterilizer (Cycle 1) The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.

Source page: https://510kreport.com/device/K222508
Methodology: https://510kreport.com/methodology