# K190260: STERIZONE (R) VP4 Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Tso3, Inc.
- Decided: Jul 19, 2019 after 161 days
- Product code: PJJ (Two Or More Sterilant Sterilizer)
- Device class: 2
- Regulation: 21 CFR 880.6860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K020875 (2003). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173694: STERIZONE VP4 Sterilizer, Tso3, Inc. (2018) Summary page 7.

## Indications for use
The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non- metal reusable medical devices in health care facilities. The single pre-set cycle of the STERIZONE® VP4 Sterilizer uses hydrogen peroxide and ozone. The injection of vaporized hydrogen peroxide is followed by the injection of ozone, which reacts with residual hydrogen peroxide to form hydroxyl radicals. Sterilization efficacy was demonstrated using a representative sample of one or more device types and packaging, in nine separate validation loads, as described in Table 1 [refer to continuation pages 2 - 4 of this form]. The load to be processed should be maintained between 20°C to 26°C (68°F to 78°F). Total load weight shall not exceed 75 lb, inclusive of the containers/packaging weight but excluding the 25 lb loading rack.

Source page: https://510kreport.com/device/K190260
Methodology: https://510kreport.com/methodology