Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Sysmex Corporation of America · 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) |
|---|---|---|---|---|---|
| K021241 | SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I | Sysmex Corporation of America | 2002-06-25 | 67 | 0 |
| K020496 | HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHA | Sysmex Corporation of America | 2002-04-12 | 57 | 0 |
| K001683 | SYSMEX R-500 | Sysmex Corporation of America | 2000-08-21 | 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