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Medical Industries America, Inc.

Country not established

Devices
19
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Medical Industries America, Inc. makes

Medical Industries America, Inc. manufactures respiratory therapy devices, including portable and stationary compressors for nebulizers (e.g., the 504 MINI COMPRESSOR, MAXI COMPRESSORS, and TRANSNEB COMPRESSOR W/NEBULIZER), aspirators for clinical suction (e.g., MAXI ASPIRATOR), and ultrasonic nebulizers (e.g., EVOLUTION ULTRASONIC). The company also produces sleep apnea therapy masks (e.g., SLEEPAP MASK) and vacuum systems (e.g., 605 VACU-MAX). Additional products include air delivery devices (e.g., 4003 AEROLITE, 3002 AEROMAX) and specialized circuit components (e.g., MINI-MICRON CIRCUIT).

The company’s devices are regulated under FDA’s 510(k) pathway, with products classified as Class I and Class II. These devices are listed in the FDA’s 510(k) registry, reflecting their compliance with U.S. medical device regulations. The manufacturer is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue19

Newest first, rows 1-19 of 19

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  • #504 Mini Compressor Ref K904045

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sleepap Mask Ref K894642

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • 605 Vacu-Max Ref K941961

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • 4003 Aerolite Ref K942208

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Maxi Aspirator Ref K902184

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mini-Micron Circuit Ref K903499

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Optima Ref K011053

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Maxi Compressors Ref K900686

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Evolution Ultrasonic Ref K894215

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • 503 Maxi Compressor Ref K940630

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Transneb Compressor W/Nebulizer, Model 5000 Ref K032170

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • 3002 Aeromax Ref K942444

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • 3000 Aerosol Two Ref K943990

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • C' Airecush Seat Cushion Ref K864109

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Remrest Ref K002763

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Remrest Heated Humidifier Ref K050990

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sleepap Ref K905593

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Push Cush Ref K864108

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • 3050 Sport-Neb Ref K964078

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-19 of 19

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

  • 2004

    • 7 Sep 2004 Z-0177-05 Unclassified (pre-2012) Terminated The nebulizer can either fail or provide a low flow (partial dose) of medication Distribution: Distribution was made to home health care providers and pharmacies nationwide. Foreign distribution was made to Italy,…
      Full distribution text Distribution was made to home health care providers and pharmacies nationwide. Foreign distribution was made to Italy, Greece, France, Poland, Japan, Hong Kong, Argentina, Australia, Israel, and Singapore.
      Submission number: K032849
    • 3 Sep 2004 Z-0326-05 Unclassified (pre-2012) Terminated Units could show an error code and stop functioning. Distribution: Distribution was made to home health care providers located in LA, NC, NY, TX, MO, CO, IA, MA, WV, IL, and FL. Foreign…
      Full distribution text Distribution was made to home health care providers located in LA, NC, NY, TX, MO, CO, IA, MA, WV, IL, and FL. Foreign distribution was made to Hong Kong, Chile, and Canada.
      Submission number: K002763

Frequently asked questions

How many devices does Medical Industries America, Inc. have in the registry?

The registry currently lists 19 devices for Medical Industries America, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Medical Industries America, Inc.'s devices?

Among its 19 most recently registered devices, Medical Industries America, Inc. has devices listed in FDA 510(k) (19 devices).

What risk classes do Medical Industries America, Inc.'s devices fall under?

Among its 19 most recently registered devices, the classes recorded for Medical Industries America, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Medical Industries America, Inc.?

FDA recall records list 2 recalls initiated by Medical Industries America, Inc., the most recent initiated on 7 Sep 2004. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Medical Industries America, Inc. in the registry?

The most recently registered devices listed for Medical Industries America, Inc. include #504 MINI COMPRESSOR, SLEEPAP MASK, 605 VACU-MAX and 4003 AEROLITE.

Generated automatically from registry data and not verified by a human reviewer.