# K120658: Durablue Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health200, LLC
- Decided: Jun 13, 2012 after 100 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: 4 generations back to K881471 (1988). 7 ancestors in all.
9 later devices descend from it; 3 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)
- K112211: Dura Blue Sterilization Wrap, Cardinal Health200, LLC (2011) Summary page 1.
- K112283: Dura Blue Sterilization Wrap, Cardinal Health200, LLC (2011) Summary page 1.
- K112918: Durablue Sterilization (Amsco V-Pro) Wrap, Cardinal Health200, LLC (2012) Summary page 1.

## Most influential descendants
- K122507: Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500 and CH600, Sterrad NX Sterilization (2012), 8 descendants of its own
- 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

## Indications for use
Cardinal Health DuraBlue TM Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by the following modalities: * Pre-vacuum steam at 270 F/132 C for 4 minutes * STERRAD® 100S system. * Lumen, Non Lumen, and Flexible Cycles in the Amsco V-PRO 1, Amsco V-PRO 1 Plus and Amsco V-PRO max Low Temperature Sterilization Systems 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: * 180 days following sterilization by STERRAD 100S and Amsco V-PRO (Lumen, Non Lumen, and Flexible Cycles). * 30 days following sterilization by pre-vacuum steam at 270 F/132 C for 4 minutes. Cardinal Health DuraBlue Sterilization Wrap is not indicated for use with gravity steam sterilization. For pre-vacuum steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200, and for 30 minutes for Models CH300, CH400, CH500 and CH600. Models CH400, CH500 and CH600 have been validated for pre-vacuum steam sterilization of lumens 3 mm in diameter or larger and 400 mm in length or less. All models have been validated for STERRAD 100S sterilization of lumens 2.5 mm in diameter or larger and 250 mm in length or less.

Source page: https://510kreport.com/device/K120658
Methodology: https://510kreport.com/methodology