# K180139: Safe Secure Sterilization Pouches and Rolls

- Pathway: 510(k) (Traditional)
- Applicant: Safe Secure Packing Co., Ltd.
- Decided: Jan 3, 2019 after 350 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: 6 generations back to K990567 (1999). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153540: Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators, Safe Secure Packaging Co., Ltd. (2016) Summary page 5.

## Most influential descendants
- K242839: Safe Secure Sterilization Pouches and Rolls (2024), 0 descendants of its own

## Indications for use
Safe Secure Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using: • Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time • Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time • Pre-vacuum steam at 134°C (273°F) for 3 minutes; 20 minutes dry time • Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time • Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F). • The recommended hydrogen peroxide vapor sterilization cycle is the STERRAD® 100S Short Cycle. The steam and EO device is not intended and has not been validated for sterilization of devices that contain lumens. The hydrogen peroxide device has been validated for devices that contain a lumen. The hydrogen peroxide device has been validated for devices that contain a lumen; the 100S has been validated for medical devices with a single stainless steel lumen with an inside diameter of ≥1mm and an length of ≤125mm as well as lumens with an inside diameter ≥2mm and a length of ≤250mm only. The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam. EO, or hydrogen peroxide sterilization process and to distinguish between processed and unprocessed devices. The chemical indicators change from green to purple after exposure to steam, from yellow to brown after exposure to ethylene oxide, and from blue to pink for hydrogen peroxide. The Tyvek version of the pouch is for EO and hydrogen peroxide sterilization only. If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 6 months after steam sterilization, 24 months after EO sterilization (for paper pouch), two years after hydrogen peroxide sterilization and five years for EO sterilization (for Tyvek Pouch). The maximum validated pouch load is 2.64 pounds (1.2kg).

Source page: https://510kreport.com/device/K180139
Methodology: https://510kreport.com/methodology