Hemcon, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Hemcon, Inc.” (first 2002, latest 2007), across 2 product codes in 2 review panels. 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 | 0 | — |
| 2016 | 0 | — |
| 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 | 4 | 4 |
| OLR | Oral Wound Dressing | 1 | 1 |
Review panels
Most recent Hemcon, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071519 | HEMCON CHITOFLEX-SURGICAL DRESSING | QSY | 2007-08-06 | 63 |
| K060363 | HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12 | OLR | 2006-07-07 | 144 |
| K043050 | HEMCON BANDAGE AND HEMCON BANDAGE OTC | QSY | 2005-06-03 | 211 |
| K030946 | HEMCON BANDAGE OTC; HEMCON CATH/AID | QSY | 2003-06-19 | 85 |
| K023298 | HEMCON BANDAGE | QSY | 2002-11-04 | 32 |
Recalls
openFDA lists no recalls under a recalling firm named Hemcon, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Hemcon Medical Technologies Europe, Ltd. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hemcon, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Hemcon, Inc.” (first 2002, latest 2007), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hemcon, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hemcon, Inc. is 85 days.
Which FDA product codes appear under Hemcon, Inc.?
The most frequent FDA product codes under this applicant name are QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics, 4); OLR (Oral Wound Dressing, 1).
Next steps
- See all 5 Hemcon, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QSY, Hemcon, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.