510(k) Report

FDA applicant

Sterilox Technologies, Inc.

Radnor, PA2 decisions2002–20060 recalls

FDA records 2 decisions for Sterilox Technologies, Inc. (Radnor, PA) from 2002 to 2006: 2 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and MED (Sterilant, Medical Devices). Its devices cite 10 predicates, 0 of them its own earlier devices. 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 Sterilox Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sterilox Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sterilox Technologies, 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?

  • FRODressing, Wound, Drug1decision
  • MEDSterilant, Medical Devices1decision

Whose devices does it build on?

Its devices cite 10 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K013280Sterilox Liquid Chemical Sterilant SystemSterilox Technologies, Inc. · 20022cite it

What has FDA decided for it lately?

  • K060901Vashe Wound Cleansing SystemSterilox Technologies, Inc. · 2006
  • K013280Sterilox Liquid Chemical Sterilant SystemSterilox Technologies, Inc. · 2002

All 2 as Sterilox Technologies, Inc. →