Medical Industries America, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Medical Industries America, Inc.” (first 1986, latest 2005), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 217 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 6 | 6 |
| BTI | Compressor, Air, Portable | 4 | 4 |
| BZD | Ventilator, Non-Continuous (Respirator) | 2 | 2 |
| KIC | Cushion, Flotation | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
| BYG | Mask, Oxygen | 1 | 1 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 1 | 1 |
| ITI | Wheelchair, Powered | 1 | 1 |
Review panels
Most recent Medical Industries America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050990 | REMREST HEATED HUMIDIFIER | BTT | 2005-05-02 | 13 |
| K032170 | TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 | CAF | 2004-05-28 | 317 |
| K002763 | REMREST | BZD | 2001-05-04 | 241 |
| K011053 | OPTIMA | ITI | 2001-04-20 | 14 |
| K964078 | 3050 SPORT-NEB | CAF | 1997-01-10 | 91 |
| K943990 | 3000 AEROSOL TWO | CAF | 1995-03-21 | 217 |
| K942444 | 3002 AEROMAX | CAF | 1995-03-10 | 291 |
| K941961 | 605 VACU-MAX | BTA | 1995-03-02 | 314 |
| K942208 | 4003 AEROLITE | CAF | 1995-02-24 | 295 |
| K940630 | 503 MAXI COMPRESSOR | BTI | 1995-02-21 | 372 |
9 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2004-09-07.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Medical Industries America, Inc. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medical Analysis Systems, Inc. (107 510(k)s)
- Medical Components, Inc. (63 510(k)s)
- Medical Advances, Inc. (57 510(k)s)
- Medical Diagnostic Technologies, Inc. (57 510(k)s)
- Medical Devices, Inc. (49 510(k)s)
- Medical Device Technologies, Inc. (46 510(k)s)
- Medical Specialties, Inc. (40 510(k)s)
- Medical Device Inspection Co., Inc. (30 510(k)s)
- Medical Engineering Corp. (28 510(k)s)
- Medical Data Electronics (27 510(k)s)
- Medical Graphics Corp. (25 510(k)s)
- Medical Innovations Corp. (24 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medical Industries America, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Medical Industries America, Inc.” (first 1986, latest 2005), across 9 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medical Industries America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Industries America, Inc. is 217 days.
Which FDA product codes appear under Medical Industries America, Inc.?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 6); BTI (Compressor, Air, Portable, 4); BZD (Ventilator, Non-Continuous (Respirator), 2).
Next steps
- See all 19 Medical Industries America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Medical Industries America, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.