# K212022: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Apr 20, 2022 after 295 days
- Product code: QKM (A Chemical Vapor Sterilization Multivariable Chemical Indicator)
- 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: 7 generations back to K921910 (1993). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203284: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator, 3M Company (2020) Summary page 5.

## Most influential descendants
- 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™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following sterilizers and cycles: - STERRAD 100S® Sterilization System - STERRAD NX® Sterilization System (Standard and Advanced cycles) - STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles) - STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles) - STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles) - V-PRO® 1 Low Temperature Sterilization System (Lumen cycle) - V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles) - V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) - V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) - V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cycles) - V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles) - STERIZONE® VP4 Sterilizer (Cycle 1)

Source page: https://510kreport.com/device/K212022
Methodology: https://510kreport.com/methodology