Medical Industries America, Inc.
Adel, IA, US
Medical Industries America, Inc. appears in FDA device records in Adel, IA. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for Medical Industries America, Inc. between 1986 and 2005. The busiest year on record is 1995, with 5. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 2 |
| 1989 | 1 |
| 1990 | 2 |
| 1991 | 4 |
| 1995 | 5 |
| 1997 | 1 |
| 2001 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K050990 | REMREST HEATED HUMIDIFIER | BTT | Substantially Equivalent | |
| K032170 | TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 | CAF | Substantially Equivalent | |
| K002763 | REMREST | BZD | Substantially Equivalent | |
| K011053 | OPTIMA | ITI | Substantially Equivalent | |
| K964078 | 3050 SPORT-NEB | CAF | Substantially Equivalent | |
| K943990 | 3000 AEROSOL TWO | CAF | Substantially Equivalent | |
| K942444 | 3002 AEROMAX | CAF | Substantially Equivalent | |
| K941961 | 605 VACU-MAX | BTA | Substantially Equivalent | |
| K942208 | 4003 AEROLITE | CAF | Substantially Equivalent | |
| K940630 | 503 MAXI COMPRESSOR | BTI | Substantially Equivalent | |
| K905593 | SLEEPAP | BZD | Substantially Equivalent | |
| K903499 | MINI-MICRON CIRCUIT | CAF | Substantially Equivalent | |
| K904045 | #504 MINI COMPRESSOR | BTI | Substantially Equivalent | |
| K902184 | MAXI ASPIRATOR | BTI | Substantially Equivalent | |
| K900686 | MAXI COMPRESSORS | BTI | Substantially Equivalent | |
| K894215 | EVOLUTION ULTRASONIC | CCQ | Substantially Equivalent | |
| K894642 | SLEEPAP MASK | BYG | Substantially Equivalent | |
| K864109 | C' AIRECUSH SEAT CUSHION | KIC | Substantially Equivalent | |
| K864108 | PUSH CUSH | KIC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- BTICompressor, Air, Portable
- KICCushion, Flotation
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- BYGMask, Oxygen
- CAFNebulizer (Direct Patient Interface)
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- BTAPump, Portable, Aspiration (Manual Or Powered)
- BZDVentilator, Non-Continuous (Respirator)
- ITIWheelchair, Powered
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0177-05 | Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Medical Industries America Inc., Adel, IA. The product is sold individually or in master packs of 8 under the following model numbers (all using the same box label): Model 7000 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual; Model 7030 - Consisting of the Aeroneb Go, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual; Model 7070 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual; Model 7000-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, European mask elbow, mouthpiece, carry bag, and user manual; Model 7030-1 - Consisting of the Aeroneb Go, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual; Model 7070-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual. 7000LINCARE - Consisting of the Aeroneb Go, battery controller with a Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual; 7070LINCARE - Consisting of the Aeroneb Go, battery controller with the Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual. | The nebulizer can either fail or provide a low flow (partial dose) of medication | Terminated | ||
| Z-0326-05 | RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903. The firm name on the device is Medical Industries America Inc., Adel, IA. | Units could show an error code and stop functioning. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain