Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intelligent Medical Devices, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140198 | IMDX HSV-1/2 FOR ABBOTT M2000 | Intelligent Medical Devices, Inc. | 2014-05-13 | 106 | 0 |
| K132235 | IMDX C.DIFFICILE FOR ABBOTT M2000 | Intelligent Medical Devices, Inc. | 2013-10-11 | 85 | 0 |
| K131584 | IMDX FLU A/B AND RSV FOR ABBOTT M2000 | Intelligent Medical Devices, Inc. | 2013-08-21 | 82 | 0 |
| K123753 | IMDX VANR FOR ABBOTT M2000 | Intelligent Medical Devices, Inc. | 2013-07-17 | 223 | 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