# K213809: 3M Attest  Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Apr 6, 2022 after 121 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). 11 ancestors in all.
1 later device descends 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)
- K192550: 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H, 3M Company (2020) Summary page 6.

## Most influential descendants
- 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
3M™ Attest™ Super Rapid Steam Biological Indicator 1592: 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, the 3SM™ 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 Gravity Displacement | 250°F (121°C) | 30 minutes Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 15, 20, 30, or 35 minutes Dynamic-air-removal (pre-vacuum and SFPP) | 270°F (132°C) | 3,3.5,4,5.5, or 6 minutes Dynamic-air-removal (pre-vacuum and SFPP) | 273°F (134°C) | 3 or 4 minutes Dynamic-air-removal (pre-vacuum and SFPP) | 275°F (135°C) | 3, 3.5, or 10 minutes 3M™ Attest™ Super Rapid Steam Challenge Pack 51582: 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, 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 Gravity Displacement | 250°F (121°C) | 30 minutes Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 30 minutes 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. The indications for use for Attest™ Biological Indicators are provided in the product’s Instructions for Use.

Source page: https://510kreport.com/device/K213809
Methodology: https://510kreport.com/methodology