510(k) Report

FDA applicant

Pulmonox Medical, Inc.

Edmonton, Ab, CA3 decisions2000–20040 recalls

FDA records 3 decisions for Pulmonox Medical, Inc. (Edmonton, Ab, CA) from 2000 to 2004: 3 510(k) clearances. Most are in product codes MRN (Apparatus, Nitric Oxide Delivery) and MRP (Analyzer, Nitric Oxide). No recall is linked to its devices.

FDA’s records also spell it “Pulmonox Medical Corp.”.

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

FIG. A — Illustration, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Pulmonox Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pulmonox Medical, 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?

  • MRNApparatus, Nitric Oxide Delivery2decisions
  • MRPAnalyzer, Nitric Oxide1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K000653Aeronox Universal, Model P/N 360000, Aeronox Bedside, Model P/N 360001, Aeronox Transport Transport, Model…Pulmonox Medical Corp. · 20002cite it
  • K023014Vianox Delivery System, Model IPulmonox Medical, Inc. · 20031cites it

What has FDA decided for it lately?

  • K033779Vianox Delivery System, Model IIPulmonox Medical, Inc. · 2004
  • K023014Vianox Delivery System, Model IPulmonox Medical, Inc. · 2003
  • K000653Aeronox Universal, Model P/N 360000, Aeronox Bedside, Model P/N 360001, Aeronox Transport Transport, Model…Pulmonox Medical Corp. · 2000

All 2 as Pulmonox Medical, Inc. →The one decision as Pulmonox Medical Corp. →