# K212198: Tyvek (R) Roll with CI for STERLINKTM Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Plasmapp Co,., Ltd.
- Decided: Oct 22, 2021 after 100 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.
3 later devices descend from it; 3 cite it directly.
0 of 9 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 6.

## Most influential descendants
- K231169: STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) (2023), 0 descendants of its own
- K223025: Tyvek Roll with CI for STERLINK Sterilizer (2023), 0 descendants of its own
- K220345: STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) (2023), 0 descendants of its own

## Indications for use
Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in 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 3.97 pounds (1.8kg). The roll is printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) 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 follow 1 type: » Sterilization roll, Flat

Source page: https://510kreport.com/device/K212198
Methodology: https://510kreport.com/methodology