# K120542: Cardinal Health Durablue Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health-Medical Products and Services
- Decided: Jun 1, 2012 after 99 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: 2 generations back to K881471 (1988). 2 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 11 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.

## Most influential descendants
- K123289: 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 be used to enclose another medical device that is to be sterilized by a health care provider by 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131 °F/55°C and 40%-80% relative humidity for 60 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 an aeration time of 8 hours at 55°C. Models CH400, CH500 and CH600 have been validated for sterilization of two lumens of 3mm diameter or larger and 400mm in length or less. Cardinal Health DuraBlue Sterilization Wrap is not indicated for use with gravity steam sterilization.

Source page: https://510kreport.com/device/K120542
Methodology: https://510kreport.com/methodology