# K192937: 3M Comply Hydrogen Peroxide Chemical Indicator

- Pathway: 510(k) (Special)
- Applicant: 3M Company
- Decided: Nov 16, 2019 after 29 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: 5 generations back to K921910 (1993). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183211: 3M Comply Hydrogen Peroxide Chemical Indicator, 3M Company (2019) Summary page 5.

## Most influential descendants
- K203458: 3M Comply Hydrogen Peroxide Chemical Indicator 1248 (2020), 1 descendant of its own
- K222508: 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 (2022), 0 descendants of its own

## 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 STERRAD® 100, STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles), STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo cycles), AMSCO® V PRO® 1 (Lumen cycle), AMSCO® V PRO® 1 Plus (Lumen and Non Lumen cycles), AMSCO® V PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible cycles), and AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cycles) sterilizers. The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.

Source page: https://510kreport.com/device/K192937
Methodology: https://510kreport.com/methodology