# K183209: 3M Comply Hydrogen Peroxide Indicator Tape

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Feb 15, 2019 after 88 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 K945190 (1994). 4 ancestors in all.
4 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)
- K170563: 3M Comply Hydrogen Peroxide Indicator Tape, 3M Company (2017) Summary page 5.

## Most influential descendants
- 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
- K222152: 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 (2022), 0 descendants 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, 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 tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide.

Source page: https://510kreport.com/device/K183209
Methodology: https://510kreport.com/methodology