# K122507: Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500 and CH600, Sterrad NX Sterilization

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health200, LLC
- Decided: Sep 26, 2012 after 40 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K881471 (1988). 8 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112283: Dura Blue Sterilization Wrap, Cardinal Health200, LLC (2011) Summary page 1.
- K120658: Durablue Sterilization Wrap, Cardinal Health200, LLC (2012) Summary page 1.

## Most influential descendants
- K123857: Durablue Sterilization Wrap (2013), 7 descendants of its own
- K132060: Durablue Sterilization Wrap (2013), 5 descendants of its own
- K151788: Cardinal Health Sterilization Wrap (2015), 4 descendants of its own
- K181174: Cardinal Health Sterilization Wrap (2018), 3 descendants of its own
- K233777: PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (2024), 1 descendant of its own

## Indications for use
Cardinal Health DuraBlue Sterilization Wrap is intended to enclose another medical device that is to be sterilized by a health care provider by the following modality: * Standard and Advanced cycles of the STERRAD NX Sterilization System The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s). Maintenance of package sterility was validated with real-time testing for the following durations: * 30 days following sterilization by STERRAD NX (Standard and Advanced cycles) All models of DuraBlue Sterilization Wrap have been validated for use with the following STERRAD NX Sterilization Cycles.

Source page: https://510kreport.com/device/K122507
Methodology: https://510kreport.com/methodology