# K071537: Sterrad 100NX Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Dec 18, 2007 after 196 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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 NX Test Pack: named in the summary without a submission number
- (no number) STERRAD CycleSure Biological Indicator: named in the summary without a submission number

## Most influential descendants
- K111391: Sterrad (R) 100NX Duo Cycle Test Pack (2012), 2 descendants of its own
- K141580: Sterizone Self-Contained Biological Indicator (2014), 1 descendant of its own
- K203560: STERIZONE VP4 Test Pack (2021), 0 descendants of its own
- K130263: Sterrad 50/100S/200 Test Pack (2014), 0 descendants of its own

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

Source page: https://510kreport.com/device/K071537
Methodology: https://510kreport.com/methodology