# K103277: 3M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490 Auto-Reader

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company-3M Health Care
- Decided: Apr 19, 2011 after 165 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: 1 generation back to K900771 (1990). 2 ancestors in all.
35 later devices descend from it; 5 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900771: Attest Brand Rapid Readout Biological Indicator, 3M Company (1990)
- K004009: 3M Attest 290 Auto-Reader, 3M Company (2002) Summary page 5.

## Most influential descendants
- K121484: 3M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM) Auto-Reader (2012), 31 descendants of its own
- 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

## Recalls of this device
- Jun 9, 2014 · Class II · Z-2002-2014: Labeling on units shipped prior to May 16th, 2014 did not contain the statement "This product contains dry natural rubber" as required by the United States Food and Drug Administration (FDA) for medic

## Indications for use
Use the 3M Attest 1491 Super Rapid Readout Biological Indicator in conjunction with the 3M Attest 490 Auto-reader to monitor the cycles below. Sterilization Type: Gravity Displacement; Temperature: 270°F (132°C); Time: 3 minutes Immediate Use Steam Sterilization Cycle (Flash); Temperature: 270°F (132°C); Time: 10 minutes Temperature: 275°F (135°C); Time: 3 minutes Temperature: 275°F (135°C); Time: 10 minutes The 3M Attest 1491 Super Rapid Readout Biological Indicator provides a final fluorescent result in 30 minutes. An optional visual pH color change result is observed in 24 hours.

Source page: https://510kreport.com/device/K103277
Methodology: https://510kreport.com/methodology