# K241123: Perpak™ Sterilization Tyvek Pouch

- Pathway: 510(k) (Traditional)
- Applicant: Km Corp.
- Decided: Sep 18, 2024 after 148 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 K921910 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180672: Sterilization Pouch/Roll Made with Tyvek, Sigma Medical Supplies Corporation (2018) Summary page 5.

## Indications for use
The Perpak™ Sterilization Tyvek Pouch is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the LOWTEM Crystal 120 Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.

Source page: https://510kreport.com/device/K241123
Methodology: https://510kreport.com/methodology