Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hem Con Medical Technologies, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
337 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153582 | Prometheus ChitoGauze XR PRO | Hem Con Medical Technologies, Inc. | 2016-05-25 | 162 | 0 |
| K150916 | HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemC | Hem Con Medical Technologies, Inc. | 2015-11-10 | 218 | 0 |
| K103641 | GUARDACARE | Hem Con Medical Technologies, Inc. | 2011-06-16 | 185 | 0 |
| K111163 | CHITOGAUZE FUSION | Hem Con Medical Technologies, Inc. | 2011-05-17 | 21 | 0 |
| K102546 | CHITOGAUZE | Hem Con Medical Technologies, Inc. | 2010-11-17 | 75 | 0 |
| K092357 | CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN | Hem Con Medical Technologies, Inc. | 2009-08-25 | 21 | 0 |
| K090026 | CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266 | Hem Con Medical Technologies, Inc. | 2009-03-31 | 85 | 0 |
| K072486 | MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC | Hem Con Medical Technologies, Inc. | 2008-08-06 | 337 | 6 |
| K080818 | HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICA | Hem Con Medical Technologies, Inc. | 2008-05-15 | 52 | 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