# K141163: Sterizone Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Tso3, Inc.
- Decided: Dec 17, 2014 after 226 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: 7 generations back to K020875 (2003). 17 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111377: Sterrad (R) 100NX Sterilizer Duo Cycle, Advanced Sterilization Products (2012) Summary page 5.
- K131120: Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization System, STERIS Corporation (2013) Summary page 5.

## Most influential descendants
- K153392: STERIZONE  VP4  Sterilizer (2016), 4 descendants of its own
- K153689: STERIZONE Sterilizer (2016), 2 descendants of its own
- K173694: STERIZONE VP4 Sterilizer (2018), 1 descendant of its own
- K190260: STERIZONE (R) VP4 Sterilizer (2019), 0 descendants of its own
- K172191: STERIZONE VP4 Sterilizer (2018), 0 descendants of its own

## 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 seven separate validation loads, as described in Table 1. 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 Ibs, inclusive of the containers/packaging weight but excluding the 25 Ibs loading rack.

Source page: https://510kreport.com/device/K141163
Methodology: https://510kreport.com/methodology