Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Celonova Biosciences, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
377 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141209 | EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-C | Celonova Biosciences, Inc. | 2014-08-07 | 90 | 0 |
| K133447 | EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-C | Celonova Biosciences, Inc. | 2014-02-24 | 104 | 0 |
| K132675 | EMBOZENE MICROSPHERES | Celonova Biosciences, Inc. | 2013-10-03 | 36 | 0 |
| K130307 | ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, | Celonova Biosciences, Inc. | 2013-03-04 | 25 | 0 |
| K073417 | EMBOZENE MICROSPHERES | Celonova Biosciences, Inc. | 2008-12-15 | 377 | 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