# K183356: Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch

- Pathway: 510(k) (Traditional)
- Applicant: Weihai Xingtai Packaging Products Co., Ltd.
- Decided: Aug 19, 2019 after 258 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)
- K162258: Self Sealing Sterilization Pouches, Tianchang Jiarui Packaging Material Co., Ltd. (2017) Summary page 5.

## Indications for use
Disposable Medical Device Self-seal Sterilization Pouch The Disposable Medical Device Self-seal Sterilization Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam autoclaves. The intended sterilization cycles are listed below: Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process. The Disposable Medical Device Self-seal Sterilization Pouch are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1600g of metal instruments. Disposable Medical Device Sterilization Reel Pouch The Disposable Medical Device Sterilization Reel Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam autoclaves. The intended sterilization cycles are listed below: Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process. The Disposable Medical Device Self-seal Sterilization Pouch are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1600g of metal instruments.

Source page: https://510kreport.com/device/K183356
Methodology: https://510kreport.com/methodology