# K993764: Medipack See-Through Seal Sterilization Pouch

- Pathway: 510(k) (Traditional)
- Applicant: Medipack Medical Packaging Mfg. Co.
- Decided: Dec 16, 1999 after 38 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: 1 generation back to K990567 (1999). 1 ancestor in all.
30 later devices descend from it; 2 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)
- K990567: Global Healthcare Self-Sealing Sterilization Pouch, Global Healthcare, Inc. (1999) Summary page 2.
- (no number) Defend Self-Sealing Sterilization Pouch: named in the summary without a submission number

## Most influential descendants
- K051242: Winner Self Seal Sterilization Pouch (2005), 29 descendants of its own
- 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

## Indications for use
The MEDIPACK® SEE-THROUGH 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 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/K993764
Methodology: https://510kreport.com/methodology