# K090569: Modification to: Attest Rapid Readout Biological Indicator, Mode 1292

- Pathway: 510(k) (Special)
- Applicant: 3M Company
- Decided: Apr 29, 2009 after 58 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: 1 generation back to K926364 (1995). 1 ancestor in all.
34 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926364: Attest Brand Rapid Readout Biological Ind. #129X, 3M Health Care, Ltd. (1995) Summary page 1.

## 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

## Indications for use
Use the Attest 1292 RRBI to monitor: 1. 250°F (1210C) gravity steam sterilization cycles. 2. 270°F (1320C) vacuum assisted steam Sterilization cycles.

Source page: https://510kreport.com/device/K090569
Methodology: https://510kreport.com/methodology