TSO3 Ozone Sterilizer, Model 125L
by Technologies of Sterilization With Oxone, Tso3, Inc.
510(k) K020875
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK020875 | Date26 Aug 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FLF
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The TSO3 Ozone Sterilizer, Model 125L is a medical device sterilizer that uses ozone gas to sterilize instruments and devices. It is designed to process medical devices sensitive to heat and moisture, including those with diffusion-restricted spaces such as the hinged portions of forceps and scissors.
The device operates at low pressure and low temperatures during the sterilization cycle. It is intended for use by healthcare providers in general hospital settings. The device is supplied as a nonportable unit and is regulated under product code FLF with device class 2 status.
Other devices from Technologies of Sterilization With Oxone, Tso3, Inc.
Questions
AI-generated answers, 23 Sep 2026
What types of instruments can the TSO3 Ozone Sterilizer Model 125L process?
It is designed for heat- and moisture-sensitive medical devices, including instruments with diffusion-restricted spaces such as the hinged portions of forceps and scissors. The low-pressure, low-temperature ozone cycle helps preserve delicate materials that could be damaged by traditional steam sterilization.
How is the TSO3 Ozone Sterilizer Model 125L supplied and installed?
The unit is supplied as a nonportable system intended for fixed installation in general hospital settings. It is not designed for mobile or transportable use and should be installed in a dedicated sterilization area with appropriate ventilation and utility connections.
Is the TSO3 Ozone Sterilizer Model 125L intended for single-use or reuse?
The device itself is a reusable sterilization system intended for repeated use across multiple sterilization cycles. However, the instruments processed within it may be single-use or reusable depending on their own manufacturer instructions and clinical guidelines.
What operating conditions does the TSO3 Ozone Sterilizer Model 125L use during its cycle?
It operates at low pressure and low temperatures throughout the sterilization cycle. These conditions are specifically engineered to protect sensitive instruments from thermal or moisture damage while still achieving effective microbial inactivation using ozone gas.
Where should the TSO3 Ozone Sterilizer Model 125L be stored and maintained?
It should be stored and operated in a controlled hospital environment with stable power, proper ventilation, and protection from extreme temperatures or humidity. Routine maintenance and performance verification should follow the manufacturer’s service schedule to ensure consistent sterilization efficacy.