# K090636: TSO3 Ozone Sterilizer, Model 125L

- Pathway: 510(k) (Traditional)
- Applicant: Tso3, Inc.
- Decided: Dec 2, 2009 after 267 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: 2 generations back to K020875 (2003). 2 ancestors in all.
22 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 2.
- K051595: TSO3 Ozone Sterilizer, Model 125L, Tso3, Inc. (2006) Summary page 2.

## Most influential descendants
- 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
- K160433: V-PRO® 1 Plus and V-PRO® maX Low Temperature (2016), 8 descendants of its own

## Indications for use
TS0 3 125L Ozone Sterilizer is intended far use in the sterilization processing of reusable medical devices in health care facilities. TSQ 125L Ozone Sterilizer is designed for sterilization of both metal and non-metal medical devices at low temperatures. TSO 3 125L Ozone Sterilizer has the ability to sterilize successfully packaged rigid and flexible lumen medical devices, including single and multi channel flexible endoscopes such as fiberoptic and video endaoscopes.

Source page: https://510kreport.com/device/K090636
Methodology: https://510kreport.com/methodology