Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Calgary Scientific, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
125 daysmedian FDA review time
161 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161130 | ResolutionMD | Calgary Scientific, Inc. | 2016-08-24 | 125 | 0 |
| K133508 | RESOLUTIONMD MOBILE | Calgary Scientific, Inc. | 2014-03-26 | 132 | 0 |
| K123186 | RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31 | Calgary Scientific, Inc. | 2013-03-14 | 154 | 0 |
| K120076 | RESOLUTIONMD WEB | Calgary Scientific, Inc. | 2012-04-19 | 100 | 0 |
| K111346 | RESOLUTIONMD MOBILE MODEL RMB-MOB-2X | Calgary Scientific, Inc. | 2011-09-09 | 119 | 0 |
| K082693 | RESOLUTIONMD, RELEASE 2.1 | Calgary Scientific, Inc. | 2009-02-23 | 161 | 0 |
| K071086 | RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0 | Calgary Scientific, Inc. | 2007-06-01 | 45 | 0 |
| K062164 | RESOLUTIONMD, VERSION 1.3 | Calgary Scientific, Inc. | 2006-09-22 | 56 | 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