Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cresilon, Inc. — 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) |
|---|---|---|---|---|---|
| K253609 | TRAUMAGEL® 2.0 Hemostatic Gel | Cresilon, Inc. | 2025-12-12 | 24 | 0 |
| K240713 | TRAUMAGEL® | Cresilon, Inc. | 2024-08-14 | 152 | 0 |
| K213652 | Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) | Cresilon, Inc. | 2023-06-28 | 586 | 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