510(k) Report

FDA applicant

Medical Industries America, Inc.

Adel, IA19 decisions1986–20051 recall

FDA records 19 decisions for Medical Industries America, Inc. (Adel, IA) from 1986 to 2005: 19 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and BTI (Compressor, Air, Portable). Its devices cite 5 predicates, 0 of them its own earlier devices. 1 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 Medical Industries America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Industries America, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medical Industries America, 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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Which product codes does it file in?

  • CAFNebulizer (Direct Patient Interface)6decisions
  • BTICompressor, Air, Portable4decisions
  • BZDVentilator, Non-Continuous (Respirator)2decisions
  • KICCushion, Flotation2decisions
  • ITIWheelchair, Powered1decision
  • CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)1decision

Also: BYG (1), BTT (1), BTA (1).

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 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.

  • K9640783050 Sport-NebMedical Industries America, Inc. · 19972cite it
  • K900686Maxi CompressorsMedical Industries America, Inc. · 19901cites it
  • K011053OptimaMedical Industries America, Inc. · 20011cites it
  • K032170Transneb Compressor W/Nebulizer, Model 5000Medical Industries America, Inc. · 20041cites it
  • K9424443002 AeromaxMedical Industries America, Inc. · 19951cites it
  • K941961605 Vacu-MaxMedical Industries America, Inc. · 19951cites it

What has FDA decided for it lately?

  • K050990Remrest Heated HumidifierMedical Industries America, Inc. · 2005
  • K032170Transneb Compressor W/Nebulizer, Model 5000Medical Industries America, Inc. · 2004
  • K002763RemrestMedical Industries America, Inc. · 20011 recall
  • K011053OptimaMedical Industries America, Inc. · 2001
  • K9640783050 Sport-NebMedical Industries America, Inc. · 1997
  • K9439903000 Aerosol TwoMedical Industries America, Inc. · 1995
  • K9424443002 AeromaxMedical Industries America, Inc. · 1995
  • K941961605 Vacu-MaxMedical Industries America, Inc. · 1995

All 19 as Medical Industries America, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K002763RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903. The firm…Sep 3, 2004