# K112918: Durablue Sterilization (Amsco V-Pro) Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health200, LLC
- Decided: Jan 20, 2012 after 109 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.
10 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092167: Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500, 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
- 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

## Indications for use
Cardinal Health DuraBlueTM Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider in the 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) for 30 days. The DuraBlueTM Sterilization Wrap was validated to be effectively aerated during the pre-programmed Amsco® V-PRO sterilization cycles.

Source page: https://510kreport.com/device/K112918
Methodology: https://510kreport.com/methodology