# K123857: Durablue Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health200, LLC
- Decided: Jan 23, 2013 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: 6 generations back to K881471 (1988). 9 ancestors in all.
7 later devices descend from it; 2 cite 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)
- K122507: Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500 and CH600, Sterrad NX Sterilization, Cardinal Health200, LLC (2012) Summary page 1.

## Most influential descendants
- 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
- K242208: PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (2024), 0 descendants of its own

## Indications for use
Cardinal Health DuraBlue Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using the following modalities: * Johnson & Johnson STERRAD® 100NX system, Standard, Flex, Express, and DUO Cycles. * Johnson & Johnson STERRAD® NX system, Standard and Advanced Cycles 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 a duration of 180 days for each indicated modality. All models of DuraBlue Sterilization Wrap have been validated for use with the following Johnson & Johnson STERRAD® 100NX and STERRAD® NX cycles in Table 1 and 2.

Source page: https://510kreport.com/device/K123857
Methodology: https://510kreport.com/methodology