# K160546: 3M Attest Rapid Readout Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Jun 9, 2016 after 104 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: 8 generations back to K994055 (2002). 15 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152060: 3M Attest Rapid Readout Biological Indicator 1295, 3M Company (2015) Summary page 4.

## Most influential descendants
- K171003: 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader (2017), 5 descendants of its own
- K173435: 3M Attest Rapid Readout Biological Indicator (2018), 4 descendants of its own
- K200996: 3M Attest Rapid Readout Biological Indicator (2020), 3 descendants of its own
- K210277: 3M Attest Rapid Readout Biological Indicator, 1295 (2021), 2 descendants of its own
- K211705: 3M Attest Rapid Readout Biological Indicator, 1295 (2022), 1 descendant of its own

## Indications for use
Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M Attest™ Auto reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the Amsco® V- PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles) and 100NX (Standard, Flex, Express and Duo cycles) systems.

Source page: https://510kreport.com/device/K160546
Methodology: https://510kreport.com/methodology