# 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)

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Oct 18, 2024 after 107 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 6.

## Indications for use
3M ™ Attest ™ Super Rapid Steam Clear Challenge Pack (1492PCD): Use the 3M ™ Attest ™ Super Rapid Steam Clear Challenge Pack 1492PCD in conjunction with the 3M ™ Attest ™ Auto-reader 490, the 3M ™ Attest ™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M ™ Attest ™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles: Cycle Type Exposure Temperature Exposure Time Dynamic-air-removal (pre-vacuum and SFPP) 270°F (132°C) 4 minutes Dynamic-air-removal (pre-vacuum and SFPP) 273°F (134°C) 4 minutes Dynamic-air-removal (pre-vacuum and SFPP) 275°F (135°C) 3 minutes 3M ™ Attest ™ Auto-reader (490): The 3M ™ Attest ™ Auto reader 490 is designed to incubate and automatically read 3M ™ Attest ™ Rapid Readout Biological Indicators 1295 and 3M ™ Attest ™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1592 at 60 ° C for a final fluorescent result at 24 minutes. 3M ™ Attest ™ Auto-reader (490H): The 3M ™ Attest ™ Auto-reader 490H is designed to incubate and automatically read 3M ™ Attest ™ Rapid Readout Biological Indicators 1295, 3M ™ Attest ™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, and 3M ™ Attest Super Rapid Steam Biological Indicators 1592 at 60 ° C for a final fluorescent result at 24 minutes. 3M ™ Attest ™ Mini Auto-reader (490M): The 3M ™ Attest ™ Mini Auto-reader 490M is designed to incubate and automatically read 3M ™ Attest ™ Rapid Readout Biological Indicators 1295 and 3M ™ Attest ™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1592, at 60 ° C for a final fluorescent result at 24 minutes.

Source page: https://510kreport.com/device/K241959
Methodology: https://510kreport.com/methodology