510(k) Report

FDA applicant

Therox, Inc.

Irvine, CA2 decisions1997–20060 recalls

FDA records 2 decisions for Therox, Inc. (Irvine, CA) from 1997 to 2006: 2 510(k) clearances. Most are in product codes DQO (Catheter, Intravascular, Diagnostic) and DQX (Wire, Guide, Catheter). Its devices cite 3 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, cardiovascular panel, where it files most

How often FDA has decided Therox, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Therox, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Therox, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Therox, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DQOCatheter, Intravascular, Diagnostic1decision
  • DQXWire, Guide, Catheter1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K052637Therox Infusion Catheter, Model Inca-1Therox, Inc. · 2006
  • K971719Therox Infusion GuidewiresTherox, Inc. · 1997

All 2 as Therox, Inc. →