# K051595: TSO3 Ozone Sterilizer, Model 125L

- Pathway: 510(k) (Traditional)
- Applicant: Tso3, Inc.
- Decided: Jul 26, 2006 after 405 days
- Product code: FLF (Sterilizer, Ethylene-Oxide Gas)
- 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: 1 generation back to K020875 (2003). 1 ancestor in all.
23 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020875: TSO3 Ozone Sterilizer, Model 125L, Technologies of Sterilization With Oxone, Tso3, Inc. (2003) Summary page 1.

## Most influential descendants
- K090636: TSO3 Ozone Sterilizer, Model 125L (2009), 22 descendants of its own
- K102330: Amsco V-Pro Max Low Temperature Sterilization System (2011), 21 descendants of its own
- K112760: Amsco V-Pro Max Low Temperature Sterilization System (2011), 18 descendants of its own
- K120632: Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization System (2012), 17 descendants of its own
- K131120: Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization System (2013), 16 descendants of its own

## Indications for use
The TSO 3 Model 125L is an Ozone Sterilizer intended for use in the sterilization processing of reusable medical devices in health care facilities. The TSO 3 O-zone Sterilizer, Model 125L. is designed for sterilization of both metal and non-metal medical devices at low temperatures. The sterilization cycle operates at very low pressure and low temperature, consequently it is suitable for processing medical devices sensitive to heat and moisture. The TSO 3 Ozone Sterilizer, Model 125l is designed to sterilize instruments and devices with diffusion-restricted spaces, such as die hinged portion of forceps and scissors.

Source page: https://510kreport.com/device/K051595
Methodology: https://510kreport.com/methodology