Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hemcon Medical Technologies Europe, Ltd. · 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) |
|---|---|---|---|---|---|
| K121485 | GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING | Hemcon Medical Technologies Europe, Ltd. | 2012-08-21 | 95 | 0 |
| K112215 | HEMCON HEMOSTATIC GEL | Hemcon Medical Technologies Europe, Ltd. | 2012-04-12 | 254 | 0 |
| K093729 | GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, S | Hemcon Medical Technologies Europe, Ltd. | 2010-06-08 | 187 | 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