Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Mountain Medical Equipment, Inc. · Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
324 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K941793 | OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.) | Mountain Medical Equipment, Inc. | 1995-06-21 | 436 | 0 |
| K923650 | SCOTTY | Mountain Medical Equipment, Inc. | 1993-01-15 | 178 | 0 |
| K924684 | MICROFLOW | Mountain Medical Equipment, Inc. | 1992-12-15 | 90 | 0 |
| K914916 | ALPINE V | Mountain Medical Equipment, Inc. | 1992-09-23 | 324 | 0 |
| K902890 | ASPEN 3 OXYGEN CONCENTRATOR | Mountain Medical Equipment, Inc. | 1990-07-19 | 17 | 0 |
| K893531 | CUFF SPECULUM | Mountain Medical Equipment, Inc. | 1989-06-22 | 45 | 0 |
| K884084 | PORTABLE OXYGEN GENERATOR | Mountain Medical Equipment, Inc. | 1988-11-21 | 55 | 0 |
| K881802 | ALPINE PORTABLE OXYGEN GENERATOR | Mountain Medical Equipment, Inc. | 1988-07-08 | 71 | 0 |
| K873677 | ECONO-MIST PORTABLE COMPRESSOR DRIVEN NEBULIZER | Mountain Medical Equipment, Inc. | 1987-10-20 | 36 | 0 |
| K873170 | ARIES | Mountain Medical Equipment, Inc. | 1987-09-25 | 45 | 0 |
| K864005 | ALPINE | Mountain Medical Equipment, Inc. | 1987-01-28 | 105 | 0 |
| K864045 | PORTABLE OXYGEN GENERATOR | Mountain Medical Equipment, Inc. | 1986-11-07 | 22 | 0 |
| K852144 | SIERRA -OXYGEN CONCENTRATE | Mountain Medical Equipment, Inc. | 1985-08-13 | 89 | 0 |
| K850253 | ECONO MATE -OXYGEN CONCENTRATOR | Mountain Medical Equipment, Inc. | 1985-02-01 | 10 | 0 |
| K843715 | ECONO MATE | Mountain Medical Equipment, Inc. | 1984-10-10 | 16 | 0 |
| K833501 | MEDI-MIST PORTA. COMPRESSOR DRIVEN | Mountain Medical Equipment, Inc. | 1983-12-12 | 68 | 0 |
| K833500 | MAX 02 OXYGEN CONCENTRATOR | Mountain Medical Equipment, Inc. | 1983-11-29 | 55 | 0 |
| K812513 | MINI O2 | Mountain Medical Equipment, Inc. | 1981-09-21 | 19 | 0 |
| K801512 | DOPPLER ULTRASONIC STETHOSCOPE | Mountain Medical Equipment, Inc. | 1980-08-20 | 51 | 0 |
| K781219 | ECON-O2 | Mountain Medical Equipment, Inc. | 1978-08-31 | 45 | 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