# K013228: 3M Comply 1248 Gas Plasma Chemical Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Minnesota Mining and Mfg. Co.
- Decided: Jan 18, 2002 after 113 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K921910 (1993). 1 ancestor in all.
14 later devices descend from it; 1 cites 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)
- K921910: Sterrad Chemical Indicator, Johnson & Johnson Medical, Inc. (1993) Summary page 1.

## Most influential descendants
- K150622: 3M Comply Hydrogen Peroxide Chemical Indicator 1248 (2015), 13 descendants of its own
- K170321: 3M Comply Hydrogen Peroxide Chemical Indicator 1248 (2017), 12 descendants of its own
- K183211: 3M Comply Hydrogen Peroxide Chemical Indicator (2019), 11 descendants of its own
- 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

## Recalls of this device
- Aug 9, 2006 · Not classified · Z-0027-2007: 3M Comply 1248 Gas Plasma Chemical Indicator Strips were manufactured with a material that may cause some of the indicators to show an inaccurate result if not read immediately after processing.

## Indications for use
The 3M™ Comply™ 1248 Gas Plasma Chemical Indicator is indicated for use as an internal pack process indicator to verify exposure to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S, and STERRAD® 50 Sterilization processes. The chemical indicator bar turns from blue to pink after exposure to vapor hydrogen peroxide in these sterilization processes.

Source page: https://510kreport.com/device/K013228
Methodology: https://510kreport.com/methodology