# K200766: 3M Attest Steam Chemical Integrator Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Jul 2, 2020 after 99 days
- Product code: FRC (Indicator, Biological 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: 6 generations back to K926364 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193154: 3M Attest Super Rapid 5 Steam-Plus Challenge Pack, 3M Company (2020) Summary page 5.

## Indications for use
Use the 3M™ Attest™ Steam Chemical Integrator Test Pack 41360 to monitor: • 121°C (250°F) gravity displacement steam sterilization cycle at 30 minutes • 132°C (270°F) dynamic-air-removal steam sterilization cycle at 4 minutes • 135°C (275°F) dynamic-air-removal steam sterilization cycle at 3 minutes

Source page: https://510kreport.com/device/K200766
Methodology: https://510kreport.com/methodology