510(k) Report

FDA applicant

Applied Membrane Technology, Inc.

Minnetonka, MN3 decisions1985–19870 recalls

FDA records 3 decisions for Applied Membrane Technology, Inc. (Minnetonka, MN) from 1985 to 1987: 3 510(k) clearances. Most are in product codes BZQ (Monitor, Breathing Frequency) and NFB (Conserver, Oxygen). 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 Applied Membrane Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Applied Membrane Technology, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Applied Membrane Technology, 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?

  • BZQMonitor, Breathing Frequency2decisions
  • NFBConserver, Oxygen1decision

What has FDA decided for it lately?

  • K870835Adult Apnea Monitor (20), Monitor Interface (30)Applied Membrane Technology, Inc. · 1987
  • K861423Demand Oxygen Saver System (D02S)Applied Membrane Technology, Inc. · 1986
  • K851235Demand Oxygen Sauer DOS2 Model 10Applied Membrane Technology, Inc. · 1985

All 3 as Applied Membrane Technology, Inc. →