# K103321: Dana Reusable Testpack for Steam Sterilization for 10 Minute Extended Cycles

- Pathway: 510(k) (Traditional)
- Applicant: Dana Products, Inc.
- Decided: Feb 16, 2011 after 96 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The disposable polypropylene sleeve assembly with 3M's 1292 BI used with the Dana Reusable Test Pack can be used for routine monitoring of 10 Minute 2700 F pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with Dana Reusable Test Pack cleared under K 092944.

Source page: https://510kreport.com/device/K103321
Methodology: https://510kreport.com/methodology