Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Millennium Biomedical, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
248 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041110 | MB 105 MILLENNIUM BLADES | Millennium Biomedical, Inc. | 2004-10-13 | 168 | 0 |
| K011833 | MB 103 MILLENNIUM BLADES | Millennium Biomedical, Inc. | 2002-02-15 | 248 | 0 |
| K020122 | MB 102 MILLENNIUM BLADES | Millennium Biomedical, Inc. | 2002-02-15 | 32 | 0 |
| K003143 | MILLENNIUM BLADES, MODEL MB101 | Millennium Biomedical, Inc. | 2000-12-11 | 62 | 0 |
| K001806 | REFRACTIVE SURGERY BLADES | Millennium Biomedical, Inc. | 2000-09-12 | 89 | 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