510(k) Report

FDA applicant

Avion Medical Products, Inc.

Burlington, Ontario, CA1 decision1997–19970 recalls

FDA records 1 decision for Avion Medical Products, Inc. (Burlington, Ontario, CA) in 1997: 1 510(k) clearance. All are in product code BZH (Meter, Peak Flow, Spirometry). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Avion Medical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Avion Medical Products, 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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