# K112591: Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process Indicators

- Pathway: 510(k) (Traditional)
- Applicant: Safe Secure Packaging Co., Ltd.
- Decided: Feb 7, 2012 after 153 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: 4 generations back to K990567 (1999). 4 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062704: Sterilization Pouch with Indicators, Winner Industries (Shenzhen) Co., Ltd. (2007) Summary page 2.
- K051242: Winner Self Seal Sterilization Pouch, Winner Medical (Usa), Inc. (2005) Summary page 2.

## Most influential descendants
- K153540: Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators (2016), 4 descendants of its own
- K180139: Safe Secure Sterilization Pouches and Rolls (2019), 1 descendant of its own
- K250306: Chex-All Sterilization Pouches and Tubes (2025), 0 descendants of its own
- K243431: Medicom Sterilization Pouch and Reel (2025), 0 descendants of its own
- K242839: Safe Secure Sterilization Pouches and Rolls (2024), 0 descendants of its own

## Indications for use
Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators Models: ABHSP, ABSSP, is intended to be used to enclose another medical device that is to be sterilized by a health provider by gravity steam and ethylene oxide. (EtO). The recommended steam sterilization cycle parameters are 30 minutes at 1210 C (250 ofl. The recommended EtO gas sterilization cycle is l35mgJL of ethylene oxide (EtO) for 1 hour at 550C (130 0 F) and 50% to 80%RH. The pouch's external chemical ink indicators on the pouches are intended to demonstrate that the device has been exposed to the steam or EtO sterilization process and to distinguish between processed and unprocessed devices. The pouch is intended to allow sterilization of the enclosed medical device and also to maintain sterility (SAL=1 0-) of the enclosed device until used.

Source page: https://510kreport.com/device/K112591
Methodology: https://510kreport.com/methodology