Derma Sciences, Inc.: FDA clearances and approvals
Derma Sciences, Inc. has 22 FDA 510(k) clearances (first 1992, latest 2015), across 4 product codes in 1 review panel. Median 510(k) review time: 74 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 2 | 414 |
| 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 | 12 | 12 |
| KMF | Bandage, Liquid | 5 | 5 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 4 | 4 |
| MGP | Dressing, Wound And Burn, Occlusive | 1 | 1 |
Review panels
Most recent Derma Sciences, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150985 | Medihoney Wound Gel | FRO | 2015-11-19 | 219 |
| K133279 | MEDIHONEY WOUND DRESSINGS | FRO | 2015-06-25 | 609 |
| K110546 | MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY | FRO | 2011-07-27 | 152 |
| K101793 | MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY | FRO | 2011-02-22 | 239 |
| K081584 | DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY | FRO | 2008-06-19 | 14 |
| K080315 | DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY | FRO | 2008-04-23 | 77 |
| K072956 | MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY | FRO | 2007-11-07 | 19 |
| K970660 | DERMAGRAN WOUND MANAGEMENT SYSTEM | KMF | 1997-08-12 | 172 |
| K963603 | DERMAGRAN HYDROPHILIC OINTMENT | KMF | 1996-11-27 | 79 |
| K954743 | DERMAGRAN WOUND DRESSING CLEANER W/ZINC | FRO | 1995-11-02 | 17 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Derma Sciences, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Derma Sciences, Inc. have?
Derma Sciences, Inc. has 22 FDA 510(k) clearances (first 1992, latest 2015), across 4 product codes in 1 review panel.
How long does FDA take to clear Derma Sciences, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Derma Sciences, Inc.'s cleared 510(k)s is 74 days.
What devices does Derma Sciences, Inc. make?
Its most frequent FDA product codes are FRO (Dressing, Wound, Drug, 12); KMF (Bandage, Liquid, 5); MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, 4).
Has Derma Sciences, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Derma Sciences, Inc. Related entities may recall under other names.
Next steps
- See all 22 Derma Sciences, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRO, Derma Sciences, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.