Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medical Industries America, Inc. · Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
217 daysmedian FDA review time
317 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050990 | REMREST HEATED HUMIDIFIER | Medical Industries America, Inc. | 2005-05-02 | 13 | 0 |
| K032170 | TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 | Medical Industries America, Inc. | 2004-05-28 | 317 | 0 |
| K002763 | REMREST | Medical Industries America, Inc. | 2001-05-04 | 241 | 1 |
| K011053 | OPTIMA | Medical Industries America, Inc. | 2001-04-20 | 14 | 0 |
| K964078 | 3050 SPORT-NEB | Medical Industries America, Inc. | 1997-01-10 | 91 | 0 |
| K943990 | 3000 AEROSOL TWO | Medical Industries America, Inc. | 1995-03-21 | 217 | 0 |
| K942444 | 3002 AEROMAX | Medical Industries America, Inc. | 1995-03-10 | 291 | 0 |
| K941961 | 605 VACU-MAX | Medical Industries America, Inc. | 1995-03-02 | 314 | 0 |
| K942208 | 4003 AEROLITE | Medical Industries America, Inc. | 1995-02-24 | 295 | 0 |
| K940630 | 503 MAXI COMPRESSOR | Medical Industries America, Inc. | 1995-02-21 | 372 | 0 |
| K905593 | SLEEPAP | Medical Industries America, Inc. | 1991-04-23 | 131 | 0 |
| K903499 | MINI-MICRON CIRCUIT | Medical Industries America, Inc. | 1991-03-27 | 236 | 0 |
| K902184 | MAXI ASPIRATOR | Medical Industries America, Inc. | 1991-02-12 | 274 | 0 |
| K904045 | #504 MINI COMPRESSOR | Medical Industries America, Inc. | 1991-02-12 | 161 | 0 |
| K900686 | MAXI COMPRESSORS | Medical Industries America, Inc. | 1990-04-26 | 72 | 0 |
| K894215 | EVOLUTION ULTRASONIC | Medical Industries America, Inc. | 1990-04-16 | 301 | 0 |
| K894642 | SLEEPAP MASK | Medical Industries America, Inc. | 1989-10-19 | 87 | 0 |
| K864108 | PUSH CUSH | Medical Industries America, Inc. | 1986-11-14 | 24 | 0 |
| K864109 | C' AIRECUSH SEAT CUSHION | Medical Industries America, Inc. | 1986-11-14 | 24 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda