# K223025: Tyvek Roll with CI for STERLINK Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Plasmapp Co,., Ltd.
- Decided: May 9, 2023 after 222 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: 5 generations back to K921910 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212198: Tyvek (R) Roll with CI for STERLINKTM Sterilizer, Plasmapp Co,., Ltd. (2021) Summary page 5.

## Indications for use
Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in pouch plus mode and chamber mode, is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERLINK™ sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 1 month post sterilization. The maximum load weight that can be placed in the Tyvek® roll is 1 Ib (450g) for pouch plus mode and 3.97 Ibs (1.8kg) for chamber mode. The roll is printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2015) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK™ sterilizer. The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in the following one type: » Sterilization roll, Flat

Source page: https://510kreport.com/device/K223025
Methodology: https://510kreport.com/methodology