Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Olympus Life Science Research Europa GmbH (Europa) · 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) |
|---|---|---|---|---|---|
| K081709 | OLYMPUS AFP - ALPHA-FETOPROTEIN | Olympus Life Science Research Europa GmbH (Europa) | 2009-03-16 | 272 | 0 |
| K080435 | OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 | Olympus Life Science Research Europa GmbH (Europa) | 2008-09-05 | 199 | 0 |
| K080094 | OLYMPUS TOTAL BHCG TEST SYSTEN | Olympus Life Science Research Europa GmbH (Europa) | 2008-09-03 | 233 | 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