# K173437: 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Mar 19, 2018 after 136 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K926364 (1995). 6 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121484: 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM) Auto-Reader, 3M Company (2012) Summary page 5.

## Most influential descendants
- K192550: 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H (2020), 2 descendants of its own
- 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
- K241710: 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader  490H; 3M™ Attest™ Mini Auto-reader  490M (2024), 0 descendants of its own
- K200092: 3MTM AttestTM Mini Auto-reader 490M (2020), 0 descendants of its own

## Recalls of this device
- Aug 22, 2023 · Class II · Z-2637-2023: 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 Readout Biological Indicator 1492V in conjunction with both the 3M™ Attest™ Auto-reader 490 or the Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal steam sterilization cycles of: • 3 minutes at 270°F (132°C) • 4 minutes at 270°F (132°C) • 3 minutes at 275°F (135°C)

Source page: https://510kreport.com/device/K173437
Methodology: https://510kreport.com/methodology