# K020875: TSO3 Ozone Sterilizer, Model 125L

- Pathway: 510(k) (Traditional)
- Applicant: Technologies of Sterilization With Oxone, Tso3, Inc.
- Decided: Aug 26, 2003 after 526 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
No predicates in its family tree.
24 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) STERRAD 100S Sterilization System: named in the summary without a submission number

## Most influential descendants
- K051595: TSO3 Ozone Sterilizer, Model 125L (2006), 23 descendants of its own
- 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

## Indications for use
The TSO3-Model 125L is an Ozone Sterilizer intended for use in the sterilization processing of reusable medical devices in Health Care Facilities. The TSO3 Model 125L Ozone Sterilizer 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 temperatures, consequently it is suitable for processing medical devices sensitive to heat and moisture. The TS03-125L Ozone Sterilizer is designed to sterilize instruments and devices with diffusion-restricted spaces, such as the hinged portion of forceps and scissors. The TS03-125L Ozone Sterilizer is also designed to process medical devices having a single stainless steel lumen with: - an inside diameter of 2 mm or larger and a length of 250 mm or shorter, - an inside diameter of 3 mm or larger and a length of 470 mm or shorter; - an inside diameter of 4 mm or larger and a length of 600 mm or shorter. Note: Testing conducted employing half cycle with a SAL of 10⁻⁶ with no survivors. The packaging compatible with the TSO3-Model 125L Ozone Sterilizer are TSO3 sterilization pouch and rigid anodized aluminum containers using disposable cellulose filter paper.

Source page: https://510kreport.com/device/K020875
Methodology: https://510kreport.com/methodology