# K133267: Dana Reusable Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: Dana Products, Inc.
- Decided: Feb 11, 2014 after 110 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K173633: VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag (2018), 2 descendants of its own
- K182931: VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag (2018), 1 descendant of its own
- K243501: 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge  Pack 1492PCDE; 3M™ Attest™ Auto-reader  490; 3M™ Attest™ Auto-reader  490H; 3M™ Attest™ Mini Auto-reader  490M (2025), 0 descendants of its own

## Indications for use
Dana Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270'F pre-vacuum steam sterilization cycles with a 3M Tm Attest TM Super Rapid Readout Biological Indicator 1492V along with or without SteriScan Integrators.

Source page: https://510kreport.com/device/K133267
Methodology: https://510kreport.com/methodology