# K192550: 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Jun 5, 2020 after 262 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: 5 generations back to K926364 (1995). 10 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K173437: 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H, 3M Company (2018) Summary page 6.
- 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 11.

## Most influential descendants
- K213809: 3M Attest  Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader (2022), 1 descendant of its own
- K242538: 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge  Pack  1493PCDG; 3M™ Attest™ Auto-reader  490; 3M™ Attest™ Auto-reader  490H; 3M™ Attest™ Mini Auto-reader  490M (2024), 0 descendants of its own

## Indications for use
Use the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor the following sterilization cycles: Cycle Type Exposure Temperature Exposure Time Dynamic-air-removal (pre-vacuum and SFPP) 250°F (121°C) 15 minutes Dynamic-air-removal (pre-vacuum and SFPP) 250°F (121°C) 20 minutes Dynamic-air-removal (pre-vacuum and SFPP) 250°F (121°C) 30 minutes Dynamic-air-removal (pre-vacuum and SFPP) 250°F (121°C) 35 minutes Gravity Displacement 250°F (121°C) 30 minutes Use the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal (pre-vacuum and SFPP) or gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C).

Source page: https://510kreport.com/device/K192550
Methodology: https://510kreport.com/methodology