Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rocky Mountain Research, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
205 daysmedian FDA review time
617 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992857 | LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL | Rocky Mountain Research, Inc. | 1999-11-10 | 77 | 0 |
| K961364 | AUTOMATIC TUBING CLAMP SYSTEM (ATC) | Rocky Mountain Research, Inc. | 1996-10-31 | 205 | 0 |
| K961598 | ELS AUTOMATIC TUBING CLAMP SYSTEM | Rocky Mountain Research, Inc. | 1996-10-29 | 203 | 0 |
| K921993 | ELS AUTOMATIC TUBING CLAMP SYSTEM | Rocky Mountain Research, Inc. | 1994-01-05 | 617 | 0 |
| K914459 | AUTOMATIC TUBING CLAMP | Rocky Mountain Research, Inc. | 1992-06-24 | 261 | 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