510(k) Report

FDA applicant

Mallard Medical, Inc.

Redding, CA2 decisions2000–20040 recalls

FDA records 2 decisions for Mallard Medical, Inc. (Redding, CA) from 2000 to 2004: 2 510(k) clearances. Most are in product codes BSZ (Gas-Machine, Anesthesia) and BZR (Mixer, Breathing Gases, Anesthesia Inhalation). 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 Mallard Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mallard 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?

  • BSZGas-Machine, Anesthesia1decision
  • BZRMixer, Breathing Gases, Anesthesia Inhalation1decision

What has FDA decided for it lately?

  • K033026Mallard Model 3000 Anesthesia MachineMallard Medical, Inc. · 2004
  • K001609Mallard Air Oxygen AccublenderMallard Medical, Inc. · 2000

All 2 as Mallard Medical, Inc. →