# K123546: 3M Attest (TM) Auto-Reader

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Mar 18, 2013 after 119 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 K004009 (2002). 2 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K004009: 3M Attest 290 Auto-Reader, 3M Company (2002) Summary page 1.
- K031012: Attest Rapid Readout Biological Indicator for EO, Model 1294; Attest Rapid Readout Biological Indicator for EO Test Pack, 3M Company (2003) Summary page 1.

## Most influential descendants
- K171587: VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator (2017), 6 descendants of its own
- K190297: Celerity HP Incubator (2019), 4 descendants of its own
- K213881: Celerity Incubator (2022), 3 descendants of its own
- K223715: Celerity Incubator (2023), 2 descendants of its own
- K250061: Celerity Incubator (2025), 0 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
The 3M Attest 390 Auto-reader is designed to incubate and automatically read the 3M Attest Rapid Readout Biological Indicators for Steam, 1291 and 1292, at 60'C for a final fluorescent result at 1 hour for 1291 and 3 hours for 1292. The 3M Attest 390G Auto-reader is designed to incubate and automatically read the 3M Attest Rapid Readout Biological Indicator for Ethylene Oxide, 1294, at 37 0 C for a final fluorescent result at 4 hours.

Source page: https://510kreport.com/device/K123546
Methodology: https://510kreport.com/methodology