# K193154: 3M Attest Super Rapid 5 Steam-Plus Challenge Pack

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Feb 7, 2020 after 85 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K926364 (1995). 9 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173519: 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader, 3M Company (2018) Summary page 5.

## Most influential descendants
- K241959: 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M) (2024), 0 descendants of its own
- K200766: 3M Attest Steam Chemical Integrator Test Pack (2020), 0 descendants of its own
- K200536: 3MTM AttestTM Rapid 5 Steam-Plus Test Pack (2020), 0 descendants of its own

## Recalls of this device
- Aug 22, 2023 · Class II · Z-2639-2023: Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) 
- Aug 22, 2023 · Class II · Z-2640-2023: Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) 

## Indications for use
Use the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the 3M™ Attest™ Auto-reader 490 or 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).

Source page: https://510kreport.com/device/K193154
Methodology: https://510kreport.com/methodology