510(k) Report

FDA applicant

Aequitron Medical, Inc.

Plymouth, MN24 decisions1984–19970 recalls

FDA records 24 decisions for Aequitron Medical, Inc. (Plymouth, MN) from 1984 to 1997: 24 510(k) clearances. Most are in product codes BZQ (Monitor, Breathing Frequency) and CBK (Ventilator, Continuous, Facility Use). 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 Aequitron Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Aequitron 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?

  • BZQMonitor, Breathing Frequency9decisions
  • CBKVentilator, Continuous, Facility Use4decisions
  • DSHRecorder, Magnetic Tape, Medical3decisions
  • HFMMonitor, Uterine Contraction, External (For Use In Clinic)2decisions
  • KRCTester, Electrode, Surface, Electrocardiographic1decision
  • CCLAnalyzer, Gas, Oxygen, Gaseous-Phase1decision

Also: CAW (1), LBI (1), DZD (1), DRT (1).

Who builds on its devices?

Later devices cite its devices 4 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.

  • K905244Model LP6 Ventilator, ModificationAequitron Medical, Inc. · 19902cite it
  • K903010Continuous Volume Ventilator Model LP10Aequitron Medical, Inc. · 19901cites it
  • K961972Model Ami Infant Central Aphea/Heart Rate MonitorAequitron Medical, Inc. · 19971cites it

What has FDA decided for it lately?

  • K961972Model Ami Infant Central Aphea/Heart Rate MonitorAequitron Medical, Inc. · 1997
  • K952880Model LP-1000 Volume VentilatorAequitron Medical, Inc. · 1996
  • K944654Oxygen Concentration IndicatorAequitron Medical, Inc. · 1994
  • K914424Model 6213 Remote AlarmAequitron Medical, Inc. · 1992
  • K915381Portable Oxygen GeneratorAequitron Medical, Inc. · 1992
  • K911399Nasal Cpap (Continuous Positive Air Pressure Syst)Aequitron Medical, Inc. · 1991
  • K903020Respiration/Heart Rate Monitor Model 9500/9550Aequitron Medical, Inc. · 1991
  • K905244Model LP6 Ventilator, ModificationAequitron Medical, Inc. · 1990

All 24 as Aequitron Medical, Inc. →