# K123289: Durablue Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health-Medical Products and Services
- Decided: Feb 28, 2013 after 129 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). 5 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 13 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.
- K120542: Cardinal Health Durablue Sterilization Wrap, Cardinal Health-Medical Products and Services (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 enclose another medical device that is to be sterilized by a health care provider using the following modalities: * Pre-vacuum steam at 270°F/132°C for 4 minutes * 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 device(s). Maintenance of package sterility was validated with real-time aging testing for a duration of 180 days for each indicated modality. For pre-vacuum steam sterilization, the wrap has been validated for dry times of 20 minutes for Models CH100 and CH200 and 30 minutes for Models CH300, CH400, CH500, and CH600. Models CH400, CH500, and CH600 have been validated for pre-vacuum steam sterilization of two lumens 3 mm in diameter or larger and 400 mm in length or less. For EO sterilization, 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 3 mm diameter or larger and 400 mm in length or less for EO sterilization.

Source page: https://510kreport.com/device/K123289
Methodology: https://510kreport.com/methodology