Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtronic Hemotec, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
213 daysmedian FDA review time
287 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954202 | PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS | Medtronic Hemotec, Inc. | 1996-06-20 | 287 | 0 |
| K944115 | HEPARIN ASSAY CARTRIDGES AND CONTROLS | Medtronic Hemotec, Inc. | 1995-03-24 | 213 | 0 |
| K940426 | MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER | Medtronic Hemotec, Inc. | 1994-09-20 | 232 | 0 |
| K923594 | CLOTTRAC COAGULATION CONTROL | Medtronic Hemotec, Inc. | 1992-09-21 | 63 | 0 |
| K922031 | HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL | Medtronic Hemotec, Inc. | 1992-07-21 | 81 | 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