Mountain Medical Equipment, Inc.: FDA clearances and approvals
Mountain Medical Equipment, Inc. has 20 FDA 510(k) clearances (first 1978, latest 1995), across 8 product codes in 3 review panels. Median 510(k) review time: 53 days.
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 |
|---|---|---|---|
| CAW | Generator, Oxygen, Portable | 12 | 12 |
| BTI | Compressor, Air, Portable | 2 | 2 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
| KPL | Colonic Irrigation System | 1 | 1 |
Plus 1 more product codes.
Review panels
- Anesthesiology (17)
- Gastroenterology and Urology (1)
- Radiology (1)
Most recent Mountain Medical Equipment, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K941793 | OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.) | CCL | 1995-06-21 | 436 |
| K923650 | SCOTTY | CAW | 1993-01-15 | 178 |
| K924684 | MICROFLOW | CAF | 1992-12-15 | 90 |
| K914916 | ALPINE V | CAW | 1992-09-23 | 324 |
| K902890 | ASPEN 3 OXYGEN CONCENTRATOR | CAW | 1990-07-19 | 17 |
| K893531 | CUFF SPECULUM | KPL | 1989-06-22 | 45 |
| K884084 | PORTABLE OXYGEN GENERATOR | CAW | 1988-11-21 | 55 |
| K881802 | ALPINE PORTABLE OXYGEN GENERATOR | CAW | 1988-07-08 | 71 |
| K873677 | ECONO-MIST PORTABLE COMPRESSOR DRIVEN NEBULIZER | BTI | 1987-10-20 | 36 |
| K873170 | ARIES | BYE | 1987-09-25 | 45 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mountain Medical Equipment, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Mountain Medical Equipment, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Mountain Medical Equipment, Inc. have?
Mountain Medical Equipment, Inc. has 20 FDA 510(k) clearances (first 1978, latest 1995), across 8 product codes in 3 review panels.
How long does FDA take to clear Mountain Medical Equipment, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Mountain Medical Equipment, Inc.'s cleared 510(k)s is 53 days.
What devices does Mountain Medical Equipment, Inc. make?
Its most frequent FDA product codes are CAW (Generator, Oxygen, Portable, 12); BTI (Compressor, Air, Portable, 2); BYE (Attachment, Breathing, Positive End Expiratory Pressure, 1).
Has Mountain Medical Equipment, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Mountain Medical Equipment, Inc. Related entities may recall under other names.
Next steps
- See all 20 Mountain Medical Equipment, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAW, Mountain Medical Equipment, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.