# K092755: Sterraad 100NX Express Cycle Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Feb 25, 2011 after 534 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 its predicate without a number.
- (no number) STERRAD® 100NX Test Pack: named in the summary without a submission number
- (no number) STERRAD® CycleSure® Biological Indicator: named in the summary without a submission number

## Indications for use
The STERRAD® 100NX™ EXPRESS Test Pack is used for routine monitoring of the STERRAD 100NX EXPRESS Sterilization cycle and is also used for the periodic testing of a STERRAD 100NX System using the hospital-defined loads in the EXPRESS cycle.

Source page: https://510kreport.com/device/K092755
Methodology: https://510kreport.com/methodology