# K200996: 3M Attest Rapid Readout Biological Indicator

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Dec 11, 2020 after 239 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: 11 generations back to K994055 (2002). 18 ancestors in all.
3 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)
- K173435: 3M Attest Rapid Readout Biological Indicator, 3M Company (2018) Summary page 5.

## Most influential descendants
- 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
- K240717: 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (2024), 0 descendants of its own

## Indications for use
Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ Auto-reader 490H or 490 Auto-reader having software version 4.0.0 or greater or 490M Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: AMSCO® V-PRO® 1 Low Temperature Sterilization System (Lumen cycle), AMSCO® V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles), AMSCO® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles), STERIS® V-PRO® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Lumen, Non Lumen, and Flexible cycles) and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with AllClear™ Technology (Standard and Advanced cycles) and STERRAD® 100NX with AllClear™ Technology (Standard, Flex, Express and Duo cycles).

Source page: https://510kreport.com/device/K200996
Methodology: https://510kreport.com/methodology