# K042450: Sterrad NX Challenge Pack

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: May 12, 2005 after 245 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.
24 later devices descend from it; 1 cites it directly.
0 of 25 devices 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 CycleSure Biological Indicator: named in the summary without a submission number
- (no number) STERRAD BI Test Pack: named in the summary without a submission number

## Most influential descendants
- K051643: Sterrad Sterilizer Cyclesure Test Pack (2005), 23 descendants of its own
- K073618: Verify Sirius Biological Indicator Challenge Pack (2009), 21 descendants of its own
- K092906: Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization (2009), 20 descendants of its own
- K103331: Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization Processes (2011), 15 descendants of its own
- K140499: Verify V24 Self-Contained Biological Indicator for Vaporized VH202 Sterilization Processes (2014), 14 descendants of its own

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

Source page: https://510kreport.com/device/K042450
Methodology: https://510kreport.com/methodology