Rocky Mountain Medical Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Rocky Mountain Medical Corp.” (first 1983, latest 1989), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| LBI | Unit, Neonatal Phototherapy | 2 | 2 |
| BRZ | Set, Blood Transfusion | 1 | 1 |
| EYQ | Garment, Protective, For Incontinence | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| FMS | Bed, Pediatric Open Hospital | 1 | 1 |
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | 1 | 1 |
| KME | Bedding, Disposable, Medical | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Rocky Mountain Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K890202 | TELE-TEMP THERMOMETER | FLL | 1989-04-05 | 78 |
| K860120 | NURSERY AMBIENT LIGHT METER | FMS | 1986-02-19 | 37 |
| K852167 | ISOVOL-EXCHANGE TRAY | BRZ | 1985-11-18 | 182 |
| K853970 | ALPHA CHUCK | KME | 1985-11-08 | 43 |
| K853790 | BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCER | HQY | 1985-10-04 | 24 |
| K851876 | PREFER INCONTINENCE AID | EYQ | 1985-06-12 | 44 |
| K834430 | OMNI INFANT PHOTOTHERAPY UNIT | LBI | 1984-04-30 | 136 |
| K832298 | BABY LIGHT DOSIMETER | LBI | 1983-10-19 | 97 |
| K837494 | BABY LIGHT METER | — | 1983-06-14 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named Rocky Mountain Medical Corp..
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.
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.
- Rocky Mountain Orthodontics, Inc. (6 510(k)s)
- Rocky Mountain Research, Inc. (5 510(k)s)
- Rocky Mountain Biosystems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Rocky Mountain Medical Corp.?
FDA lists 9 510(k) clearances under the applicant name “Rocky Mountain Medical Corp.” (first 1983, latest 1989), across 8 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 Rocky Mountain Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rocky Mountain Medical Corp. is 56 days.
Which FDA product codes appear under Rocky Mountain Medical Corp.?
The most frequent FDA product codes under this applicant name are LBI (Unit, Neonatal Phototherapy, 2); BRZ (Set, Blood Transfusion, 1); EYQ (Garment, Protective, For Incontinence, 1).
Next steps
- See all 9 Rocky Mountain Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code LBI, Rocky Mountain Medical Corp.'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.