# K173584: 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Jan 22, 2018 after 63 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: 2 generations back to K900771 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103277: 3M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490 Auto-Reader, 3M Company-3M Health Care (2011) Summary page 5.

## Indications for use
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 in conjunction with the 3M™ Attest™ Auto-reader 490 or 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to monitor the cycles below. Sterilization Type Temperature Time 270°F (132°C) 3 minutes Gravity Displacement 270°F (132°C) 10 minutes Steam Sterilization Cycle 275°F (135°C) 3 minutes 275°F (135°C) 10 minutes

Source page: https://510kreport.com/device/K173584
Methodology: https://510kreport.com/methodology