# K121484: 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM) Auto-Reader

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Oct 19, 2012 after 154 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 K926364 (1995). 5 ancestors in all.
31 later devices descend from it; 4 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090569: Modification to: Attest Rapid Readout Biological Indicator, Mode 1292, 3M Company (2009) Summary page 1.
- K926364: Attest Brand Rapid Readout Biological Ind. #129X, 3M Health Care, Ltd. (1995) Summary page 1.
- K103277: 3M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490 Auto-Reader, 3M Company-3M Health Care (2011) Summary page 1.

## Most influential descendants
- K140392: 3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader (2014), 12 descendants of its own
- K152060: 3M Attest Rapid Readout Biological Indicator 1295 (2015), 11 descendants of its own
- K121593: 3M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest (TM) Super Rapid 5 Steam-Plus Challenge Pack (2013), 11 descendants of its own
- 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 (2018), 7 descendants of its own
- K160546: 3M Attest Rapid Readout Biological Indicator (2016), 6 descendants of its own

## Indications for use
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in conjunction with the 3M™ Attest™ Auto-reader 490 to qualify or monitor dynamic-air-removal (prevacuum) steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C). The 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V provides a final fluorescent result in 1 hour. An optional visual pH color change result is observed in 48 hours.

Source page: https://510kreport.com/device/K121484
Methodology: https://510kreport.com/methodology