Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Olympus Life & Material Science Europa GmbH (Irish · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070708 | OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MOD | Olympus Life & Material Science Europa GmbH (Irish | 2007-08-21 | 160 | 0 |
| K070453 | OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CAL | Olympus Life & Material Science Europa GmbH (Irish | 2007-06-11 | 115 | 0 |
| K070835 | OLYMPUS CK-MB REAGENT | Olympus Life & Material Science Europa GmbH (Irish | 2007-06-04 | 69 | 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