# K150694: 3M Comply Hydrogen Peroxide Indicator Tape 1228

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Oct 1, 2015 after 197 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 K945190 (1994). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020589: 3M Comply 1228 Gas Plasma Indicator Tape, 3M Company (2002) Summary page 4.

## Most influential descendants
- K170563: 3M Comply Hydrogen Peroxide Indicator Tape (2017), 5 descendants of its own
- K183209: 3M Comply Hydrogen Peroxide Indicator Tape (2019), 4 descendants of its own
- K192673: 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 (2019), 3 descendants of its own
- K203285: 3M Comply Hydrogen Peroxide Indicator Tape 1228 (2020), 2 descendants of its own
- K212081: 3M (TM) Comply (TM) Hydrogen Peroxide Indicator Tape 1228 (2021), 1 descendant of its own

## Indications for use
Use the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 to secure packs and as an external pack process indicator to differentiate unprocessed items from items processed in the STERRAD® 100, 100S, NX® (Standard and Advanced cycles) and 100NX® (Standard, Flex, Express and Duo cycles) sterilization processes. The tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue to pink after exposure to vaporized hydrogen peroxide.

Source page: https://510kreport.com/device/K150694
Methodology: https://510kreport.com/methodology