Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biosurgical Corp. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000438 | MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER | Biosurgical Corp. | 2000-05-03 | 83 | 0 |
| K000048 | SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL | Biosurgical Corp. | 2000-01-31 | 24 | 0 |
| K992351 | SEALOUETTE FIBRIN SEALANT APPLICATOR | Biosurgical Corp. | 1999-10-08 | 86 | 0 |
| K964597 | BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE | Biosurgical Corp. | 1997-09-08 | 294 | 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