# K193110: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

- Pathway: 510(k) (Traditional)
- Applicant: 3M Healthcare
- Decided: Mar 13, 2020 after 122 days
- Product code: QKM (A Chemical Vapor Sterilization Multivariable Chemical Indicator)
- 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: 5 generations back to K921910 (1993). 5 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183211: 3M Comply Hydrogen Peroxide Chemical Indicator, 3M Company (2019) Summary page 5.

## Most influential descendants
- K203284: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator (2020), 6 descendants of its own
- K213262: CELERITY HP Chemical Indicator (2022), 3 descendants of its own
- K231488: Celerity™ HP Chemical Indicator;  Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape (2023), 2 descendants of its own
- K240760: CELERITY HP Indicator Tape (2024), 1 descendant of its own
- K212022: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (2022), 1 descendant of its own

## Recalls of this device
- May 25, 2022 · Class III · Z-1794-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

## Indications for use
Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilization sterilizers and cycles: STERRAD™ 100S System, STERRAD™ NX™ System (Standard and Advanced cycles), STERRAD™ NX™ System with AIIClear™ Technology (Standard and Advanced cycles), STERRAD™ 100NX™ System (Standard, Flex, Express and Duo cycles) STERRAD™ 100NX™ System with AIIClear™ Technology (Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and STERIS™ V-PRO™ 1 (Lumen cycle), STERIS™ V-PRO™ 1 Plus (Lumen and Non-Lumen cycles) and STERIS™ V-PRO™ maX Low Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), STERIS™ V-PRO™ 60 Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), and STERIS™ V-PRO™ maX 2 Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles).

Source page: https://510kreport.com/device/K193110
Methodology: https://510kreport.com/methodology