Rocky Mountain Research, Inc.: FDA clearances and approvals
Rocky Mountain Research, Inc. has 5 FDA 510(k) clearances (first 1992, latest 1999), across 3 product codes in 2 review panels. Median 510(k) review time: 205 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 |
|---|---|---|---|
| FIG | Clamp, Tubing, Blood, Automatic | 2 | 2 |
| KRL | Detector, Bubble, Cardiopulmonary Bypass | 2 | 2 |
| DTW | Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass | 1 | 1 |
Review panels
Most recent Rocky Mountain Research, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992857 | LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 | DTW | 1999-11-10 | 77 |
| K961364 | AUTOMATIC TUBING CLAMP SYSTEM (ATC) | KRL | 1996-10-31 | 205 |
| K961598 | ELS AUTOMATIC TUBING CLAMP SYSTEM | KRL | 1996-10-29 | 203 |
| K921993 | ELS AUTOMATIC TUBING CLAMP SYSTEM | FIG | 1994-01-05 | 617 |
| K914459 | AUTOMATIC TUBING CLAMP | FIG | 1992-06-24 | 261 |
Recalls
openFDA lists no recalls under a recalling firm named Rocky Mountain Research, 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.
Frequently asked questions
How many FDA 510(k) clearances does Rocky Mountain Research, Inc. have?
Rocky Mountain Research, Inc. has 5 FDA 510(k) clearances (first 1992, latest 1999), across 3 product codes in 2 review panels.
How long does FDA take to clear Rocky Mountain Research, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Rocky Mountain Research, Inc.'s cleared 510(k)s is 205 days.
What devices does Rocky Mountain Research, Inc. make?
Its most frequent FDA product codes are FIG (Clamp, Tubing, Blood, Automatic, 2); KRL (Detector, Bubble, Cardiopulmonary Bypass, 2); DTW (Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass, 1).
Has Rocky Mountain Research, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Rocky Mountain Research, Inc. Related entities may recall under other names.
Next steps
- See all 5 Rocky Mountain Research, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FIG, Rocky Mountain Research, 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.