# K111391: Sterrad (R) 100NX Duo Cycle Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Sep 26, 2012 after 497 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 K071537 (2007). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071537: Sterrad 100NX Test Pack, Advanced Sterilization Products (2007) Summary page 1.

## Most influential descendants
- K141580: Sterizone Self-Contained Biological Indicator (2014), 1 descendant of its own
- K203560: STERIZONE VP4 Test Pack (2021), 0 descendants of its own

## Indications for use
The STERRAD® 100NX® DUO Cycle Test Pack is used for routine monitoring of the STERRAD® 100NX® DUO Sterilization Cycle and is also used for the periodic testing of a STERRAD® 100NX® System DUO Cycle, using hospital-defined loads containing devices that do not exceed claims of the cycle. The STERRAD® 100NX® DUO Cycle Test Pack consists of a STERRAD® CYCLESURE® 24 Biological Indicator, vial and cap to hold the BI.

Source page: https://510kreport.com/device/K111391
Methodology: https://510kreport.com/methodology