# K200536: 3MTM AttestTM Rapid 5 Steam-Plus Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: 3M Complany
- Decided: Jun 1, 2020 after 90 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
3M™ Attest™ Rapid 5 Steam-Plus Test Pack 41382: Use the 3M™ Attest™ Rapid 5 Steam-Plus Test Pack 41382 to qualify or monitor: • 121°C (250°F) 30-minute gravity steam sterilization cycles; • 132°C (270°F) 4-minute dynamic-air-removal steam sterilization cycles.

Source page: https://510kreport.com/device/K200536
Methodology: https://510kreport.com/methodology