# K051643: Sterrad Sterilizer Cyclesure Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Aug 19, 2005 after 60 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
Longest line of descent: 1 generation back to K042450 (2005). 1 ancestor in all.
23 later devices descend from it; 2 cite 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)
- K042450: Sterrad NX Challenge Pack, Advanced Sterilization Products (2005) Summary page 1.

## Most influential descendants
- 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
- K171504: VERIFY Assert VH2O2 Self-Contained Biological Indicator (2017), 9 descendants of its own

## Indications for use
The STERRAD® Sterilizer CycleSure® Test Pack is used for routine monitoring of the STERRAD 50, STERRAD 100S and STERRAD 200 Sterilizers and is also used for the periodic testing of these sterilizers using hospital-defined loads.

Source page: https://510kreport.com/device/K051643
Methodology: https://510kreport.com/methodology