Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tokyo Boeki Medisys, Inc. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110520 | BIOLIS 12I | Tokyo Boeki Medisys, Inc. | 2012-03-23 | 394 | 0 |
| K103531 | PRESTIGE 24I; BIOLIS 24I; MGC 240 | Tokyo Boeki Medisys, Inc. | 2011-12-01 | 365 | 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