# K112211: Dura Blue Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health200, LLC
- Decided: Oct 20, 2011 after 79 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: 3 generations back to K881471 (1988). 3 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082177: Kimguard One-Step Sterilization Wrap, Kimberly-Clark Corp. (2009) Summary page 1.
- K091685: Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC 500, KC600, Kimberly-Clark Corp. (2009) Summary page 1.

## Most influential descendants
- K120658: Durablue Sterilization Wrap (2012), 9 descendants of its own
- K122507: Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500 and CH600, Sterrad NX Sterilization (2012), 8 descendants of its own
- K123289: Durablue Sterilization Wrap (2013), 7 descendants of its own
- K123857: Durablue Sterilization Wrap (2013), 7 descendants of its own
- K132060: Durablue Sterilization Wrap (2013), 5 descendants of its own

## Indications for use
Cardinal Health Durasluem Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 2700 F11 32C for 4 minutes. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed devices for 30 days. The wrap has been validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models CHiG00 and CH200, and for 30 minutes for Models CH300, CH400, CH500 and CHOOO. Models 0H400, CH500 and CH600 have been validated for sterilization of lumens of 3mm diameter or lamger and 400mm in length or less. Cardinal Health DuraBluetm Sterilization Wrap is not indicated for use with gravity steam sterilization.

Source page: https://510kreport.com/device/K112211
Methodology: https://510kreport.com/methodology