# K140392: 3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Aug 13, 2014 after 180 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 K994055 (2002). 13 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123017: Sterrad Cyclesure 24 Biological Indicator Model 14324, Advanced Sterilization Products (2012) Summary page 5.
- K121484: 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM) Auto-Reader, 3M Company (2012) Summary page 5.
- K103277: 3M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490 Auto-Reader, 3M Company-3M Health Care (2011) Summary page 6.

## Most influential descendants
- K152060: 3M Attest Rapid Readout Biological Indicator 1295 (2015), 11 descendants of its own
- K160546: 3M Attest Rapid Readout Biological Indicator (2016), 6 descendants of its own
- K171003: 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader (2017), 5 descendants of its own
- K173435: 3M Attest Rapid Readout Biological Indicator (2018), 4 descendants of its own
- K200996: 3M Attest Rapid Readout Biological Indicator (2020), 3 descendants of its own

## Indications for use
Use the 3M Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M Attest™ Auto-reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in STERRAD® NX and 100NX systems.

Source page: https://510kreport.com/device/K140392
Methodology: https://510kreport.com/methodology