# K051242: Winner Self Seal Sterilization Pouch

- Pathway: 510(k) (Traditional)
- Applicant: Winner Medical (Usa), Inc.
- Decided: Dec 13, 2005 after 214 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- 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 K990567 (1999). 2 ancestors in all.
29 later devices descend from it; 5 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993764: Medipack See-Through Seal Sterilization Pouch, Medipack Medical Packaging Mfg. Co. (1999) Summary page 1.
- K990567: Global Healthcare Self-Sealing Sterilization Pouch, Global Healthcare, Inc. (1999) Summary page 1.

## Most influential descendants
- K070428: Medicom Self-Sealing Sterilization Pouch (2007), 19 descendants of its own
- K102158: Sigma Sterilization Pouch & Roll (2011), 16 descendants of its own
- K062704: Sterilization Pouch with Indicators (2007), 7 descendants of its own
- K112591: Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process Indicators (2012), 6 descendants of its own
- K212338: SterileRight sterilization pouch and roll (2021), 5 descendants of its own

## Indications for use
Winner® Self Seal Sterilization Pouch is intended to be used to enclose another medical device that is to be sterilized by a health provider by steam 1210C for 15 minutes or ethylene oxide (EtO). It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Source page: https://510kreport.com/device/K051242
Methodology: https://510kreport.com/methodology