510(k) Report

FDA applicant

Diros Technology, Inc.

Markham, Ontario, CA8 decisions2002–20170 recalls

FDA records 8 decisions for Diros Technology, Inc. (Markham, Ontario, CA) from 2002 to 2017: 8 510(k) clearances. Most are in product codes GXI (Probe, Radiofrequency Lesion) and GXD (Generator, Lesion, Radiofrequency). Its devices cite 17 predicates, 5 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, neurology panel, where it files most

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

FDA decisions per year

1in 2017

2010: 12011: 22014: 12015: 12017: 1
2007high 2 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Diros Technology, 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?

  • GXIProbe, Radiofrequency Lesion5decisions
  • GXDGenerator, Lesion, Radiofrequency3decisions

Whose devices does it build on?

Its devices cite 17 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 5 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.

  • K141586Owl CannulaeDiros Technology, Inc. · 20142cite it
  • K021869Owl Radiofrequency System, Model Urf-2APDiros Technology, Inc. · 20022cite it
  • K102566Owl CannulaeDiros Technology, Inc. · 20112cite it
  • K110593Owl RF ProbesDiros Technology, Inc. · 20111cites it
  • K062758Owl Urf-3APDiros Technology, Inc. · 20061cites it

What has FDA decided for it lately?

  • K170708Owl RF Insulated CannulaeDiros Technology, Inc. · 2017
  • K150371Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRHDiros Technology, Inc. · 2015
  • K141586Owl CannulaeDiros Technology, Inc. · 2014
  • K102566Owl CannulaeDiros Technology, Inc. · 2011
  • K110593Owl RF ProbesDiros Technology, Inc. · 2011
  • K093185Owl Universal RF System Urf-3AP (ML)Diros Technology, Inc. · 2010
  • K062758Owl Urf-3APDiros Technology, Inc. · 2006
  • K021869Owl Radiofrequency System, Model Urf-2APDiros Technology, Inc. · 2002

All 8 as Diros Technology, Inc. →