510(k) Report

FDA applicant

Technologies of Sterilization With Oxone, Tso3, Inc.

Fairport, NY2 decisions2003–20030 recalls

FDA records 2 decisions for Technologies of Sterilization With Oxone, Tso3, Inc. (Fairport, NY) in 2003: 2 510(k) clearances. Most are in product codes FLF (Sterilizer, Ethylene-Oxide Gas) and JOJ (Indicator, Physical/Chemical Sterilization…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Technologies of Sterilization With Oxone, Tso3, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Technologies of Sterilization With Oxone, Tso3, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Technologies of Sterilization With Oxone, Tso3, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FLFSterilizer, Ethylene-Oxide Gas1decision
  • JOJIndicator, Physical/Chemical Sterilization Process1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K020875TSO3 Ozone Sterilizer, Model 125LTechnologies of Sterilization With Oxone, Tso3, Inc. · 20032cite it

What has FDA decided for it lately?

  • K021161TSO3 Ozone Chemical IndicatorTechnologies of Sterilization With Oxone, Tso3, Inc. · 2003
  • K020875TSO3 Ozone Sterilizer, Model 125LTechnologies of Sterilization With Oxone, Tso3, Inc. · 2003

All 2 as Technologies of Sterilization With Oxone, Tso3, Inc. →