# K092944: Dana Reusable Test Pack for Steam Sterilization

- Pathway: 510(k) (Traditional)
- Applicant: Dana Products, Inc.
- Decided: Mar 18, 2010 after 175 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## 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-vaculum steam sterilization cycles. It is validated to be used in 4 minute 270'F pre-vacuum steam sterilization cycles with 3M's 1292 Rapid Readout Biological Indicators along with or without SteriScan Integrators.

Source page: https://510kreport.com/device/K092944
Methodology: https://510kreport.com/methodology