# K926364: Attest Brand Rapid Readout Biological Ind. #129X

- Pathway: 510(k) (Traditional)
- Applicant: 3M Health Care, Ltd.
- Decided: Mar 31, 1995 after 829 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
No predicates in its family tree.
35 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K090569: Modification to: Attest Rapid Readout Biological Indicator, Mode 1292 (2009), 34 descendants of its own
- 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

Source page: https://510kreport.com/device/K926364
Methodology: https://510kreport.com/methodology