# K020589: 3M Comply 1228 Gas Plasma Indicator Tape

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Apr 22, 2002 after 59 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: 1 generation back to K945190 (1994). 1 ancestor in all.
7 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)
- K945190: Sterrad Chemical Indicator Tape, Advanced Sterilization Products (1994) Summary page 2.

## Most influential descendants
- K150694: 3M Comply Hydrogen Peroxide Indicator Tape 1228 (2015), 6 descendants of its own
- 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

## Indications for use
The 3M™ Comply™ 1228 Gas Plasma Indicator Tape is indicated for use to secure packs and as an external pack indicator to differentiate processed from unprocessed items when exposure to vapor hydrogen peroxide in the STERRAD® sterilization processes (100, 100S, 50). The 3M Comply 1228 is suitable for use on non-woven disposable wraps and peel pouches. The diagonal stripes of chemical indicator ink turn from blue to pink after exposure to vapor hydrogen peroxide in these sterilization processes.

Source page: https://510kreport.com/device/K020589
Methodology: https://510kreport.com/methodology