Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mitsubishi Kagaku Iatron · 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) |
|---|---|---|---|---|---|
| K081360 | PATHFAST CK-MB-II, PATHFAST MYO-II | Mitsubishi Kagaku Iatron | 2009-08-17 | 459 | 0 |
| K072288 | PATHFAST D-DIMER | Mitsubishi Kagaku Iatron | 2009-05-06 | 629 | 1 |
| K083412 | PATHFAST HSCRP | Mitsubishi Kagaku Iatron | 2009-03-09 | 111 | 0 |
| K072189 | PATHFAST NTPROBNP AND D-DIMER TESTS | Mitsubishi Kagaku Iatron | 2008-02-05 | 183 | 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