# K183211: 3M Comply Hydrogen Peroxide Chemical Indicator

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Feb 26, 2019 after 99 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: 4 generations back to K921910 (1993). 4 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170321: 3M Comply Hydrogen Peroxide Chemical Indicator 1248, 3M Company (2017) Summary page 5.

## Most influential descendants
- K193110: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (2020), 7 descendants of its own
- K203284: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator (2020), 6 descendants of its own
- K213262: CELERITY HP Chemical Indicator (2022), 3 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
- K192937: 3M Comply Hydrogen Peroxide Chemical Indicator (2019), 2 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, 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) and AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) sterilizers. The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.

Source page: https://510kreport.com/device/K183211
Methodology: https://510kreport.com/methodology