Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hemcon, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
211 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K071519 | HEMCON CHITOFLEX-SURGICAL DRESSING | Hemcon, Inc. | 2007-08-06 | 63 | 0 |
| K060363 | HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, | Hemcon, Inc. | 2006-07-07 | 144 | 0 |
| K043050 | HEMCON BANDAGE AND HEMCON BANDAGE OTC | Hemcon, Inc. | 2005-06-03 | 211 | 0 |
| K030946 | HEMCON BANDAGE OTC; HEMCON CATH/AID | Hemcon, Inc. | 2003-06-19 | 85 | 0 |
| K023298 | HEMCON BANDAGE | Hemcon, Inc. | 2002-11-04 | 32 | 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