# K241542: 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)

- Pathway: 510(k) (Special)
- Applicant: 3M Company
- Decided: Jun 27, 2024 after 27 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: 7 generations back to K042450 (2005). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233814: 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™ Attest™ Auto-reader  (490); 3M™ Attest™ Auto-reader  (490H); 3M™ Attest™ Mini Auto-reader  (490M), 3M Company (2024) Summary page 6.

## Indications for use
Use the 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3M™ Attest™ Mini Auto-reader 490M or a 3M™ Attest™ Auto-reader 490H as a standard method of routine monitoring and performance qualification of vaporized hydrogen peroxide sterilization processes in the follow systems: 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) SteroScope® Sterilization System

Source page: https://510kreport.com/device/K241542
Methodology: https://510kreport.com/methodology