# K132060: Durablue Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health-Medical Products and Services
- Decided: Dec 13, 2013 after 163 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: 7 generations back to K881471 (1988). 12 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123857: Durablue Sterilization Wrap, Cardinal Health200, LLC (2013) Summary page 1.
- K123289: Durablue Sterilization Wrap, Cardinal Health-Medical Products and Services (2013) Summary page 1.
- K120658: Durablue Sterilization Wrap, Cardinal Health200, LLC (2012) Summary page 11.

## Most influential descendants
- 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
- K222151: Sterilization Wrap (2023), 0 descendants of its own

## Indications for use
DuraBlue™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using: * 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 * Advanced Sterilization Products (ASP) STERRAD® 100S system. * Advanced Sterilization Products (ASP) STERRAD® NX system, Standard and Advanced Cycles * Advanced Sterilization Products (ASP) STERRAD® 100NX system, Standard, Flex, Express, and DUO Cycles * 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) until used. 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 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 EO sterilization of two lumens 3 mm in diameter or larger and 400 mm in length or less. All models of DuraBlue™ Sterilization Wrap have been validated for Advanced Sterilization Products (ASP) STERRAD® 100S sterilization of lumens 2.5 mm in diameter or larger and 250 mm in length or less. All models of DuraBlue™ Sterilization Wrap have been validated for use with the Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX cycles in Table 1. All models of DuraBlue™ Sterilization Wrap have been validated for use with the STERIS Amsco® V-PRO® cycles in Table 2. The DuraBlue™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed STERIS Amsco® V-PRO® sterilization cycles.

Source page: https://510kreport.com/device/K132060
Methodology: https://510kreport.com/methodology