# K070428: Medicom Self-Sealing Sterilization Pouch

- Pathway: 510(k) (Traditional)
- Applicant: A.R. Medicom, Inc.
- Decided: Jul 17, 2007 after 154 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: 3 generations back to K990567 (1999). 3 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051242: Winner Self Seal Sterilization Pouch, Winner Medical (Usa), Inc. (2005) Summary page 1.

## Most influential descendants
- K102158: Sigma Sterilization Pouch & Roll (2011), 16 descendants of its own
- K212338: SterileRight sterilization pouch and roll (2021), 5 descendants of its own
- K143637: U&U Sterilization Pouch and Roll (2015), 4 descendants of its own
- K221875: Sterilization Pouch and Roll (2023), 3 descendants of its own
- K180661: SIGMA Sterilization Pouch and Roll (2018), 2 descendants of its own

## Indications for use
The self-sealing sterilization pouches are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 100 - 120 minutes at 50 °C with a relative humidity between 60 - 85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch maintains the enclosed devices sterile up until one year post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.

Source page: https://510kreport.com/device/K070428
Methodology: https://510kreport.com/methodology