# K203560: STERIZONE VP4 Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: Tso3 Inc., Now A Part of Stryker
- Decided: Mar 24, 2021 after 107 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- 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 K994055 (2002). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141580: Sterizone Self-Contained Biological Indicator, Tso3, Inc. (2014) Summary page 5.

## Indications for use
The STERIZONE@ VP4 Test Pack is intended to be used for routine monitoring of the STERIZONE@ VP4 Sterilizer cycle (Cycle 1) and for the performance validation of the STERIZONE@ VP4 Sterilizer system.

Source page: https://510kreport.com/device/K203560
Methodology: https://510kreport.com/methodology