The Hymed Group Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “The Hymed Group Corp.” (first 1996, latest 2014), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 162 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 | 1 | 276 |
| 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 2 | 2 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 2 | 2 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 2 | 2 |
Review panels
Most recent The Hymed Group Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132891 | HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER | FRO | 2014-06-19 | 276 |
| K061227 | HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER | FRO | 2006-12-20 | 232 |
| K994339 | HYCURE ORAL / HYCURE ORAL SMART GEL | KGN | 2000-03-22 | 90 |
| K961930 | CHONDROPROTEC | MGQ | 1996-10-15 | 151 |
| K960686 | HYCOAT | MGQ | 1996-08-12 | 174 |
| K955506 | HYCURE | KGN | 1996-01-17 | 47 |
Recalls
openFDA lists no recalls under a recalling firm named The Hymed Group Corp..
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 The Hymed Group Corp.?
FDA lists 6 510(k) clearances under the applicant name “The Hymed Group Corp.” (first 1996, latest 2014), across 3 product codes 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 The Hymed Group Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Hymed Group Corp. is 162 days.
Which FDA product codes appear under The Hymed Group Corp.?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 2); KGN (Wound Dressing With Animal-Derived Material(S), 2); MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, 2).
Next steps
- See all 6 The Hymed Group Corp. clearances with predicates and recalls
- Run predicate analysis for product code FRO, The Hymed Group Corp.'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.