Hem Con Medical Technologies, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Hem Con Medical Technologies, Inc.” (first 2008, latest 2016), across 1 product code in 1 review panel. Median 510(k) review time under this name: 85 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 218 |
| 2016 | 1 | 162 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | 9 | 9 |
Review panels
Most recent Hem Con Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153582 | Prometheus ChitoGauze XR PRO | QSY | 2016-05-25 | 162 |
| K150916 | HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO | QSY | 2015-11-10 | 218 |
| K103641 | GUARDACARE | QSY | 2011-06-16 | 185 |
| K111163 | CHITOGAUZE FUSION | QSY | 2011-05-17 | 21 |
| K102546 | CHITOGAUZE | QSY | 2010-11-17 | 75 |
| K092357 | CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2 | QSY | 2009-08-25 | 21 |
| K090026 | CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266 | QSY | 2009-03-31 | 85 |
| K072486 | MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC | QSY | 2008-08-06 | 337 |
| K080818 | HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING | QSY | 2008-05-15 | 52 |
Recalls
openFDA lists no recalls under a recalling firm named Hem Con Medical Technologies, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Hem Con Medical Technologies, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Hem Con Medical Technologies, Inc.” (first 2008, latest 2016), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hem Con Medical Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hem Con Medical Technologies, Inc. is 85 days.
Which FDA product codes appear under Hem Con Medical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics, 9).
Next steps
- See all 9 Hem Con Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QSY, Hem Con Medical Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.