# K251347: Sterilization Pouch/Roll

- Pathway: 510(k) (Traditional)
- Applicant: Sterivic Medical Co., Ltd.
- Decided: Jan 28, 2026 after 273 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: 7 generations back to K990567 (1999). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221875: Sterilization Pouch and Roll, Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. (2023) Summary page 8.

## Indications for use
The Sterilization Pouch/Roll is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows: • Steam Sterilization at 132° C (270 ° F) for 4 minutes; Drying time of 20 minutes. • Ethylene Oxide (EO) with a concentration of 695 mg/Lat 50° C (122° F) and 30% to 90% relative humidity for 4 hour. Aeration time of 7 days at room temperature. The Sterilization Pouch/Roll is made with medical grade paper and medical compound film. The Sterilization Pouch/Roll maintains the sterility of the enclosed devices for up to 6 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture. 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. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from Pink before sterilization to Yellow after sterilization. The steam sterilization indicator color change from Blue before sterilization to Black after sterilization. The specification and recommended sterilization load of the device is following: see attached page

Source page: https://510kreport.com/device/K251347
Methodology: https://510kreport.com/methodology