Biodermis Corp.: FDA clearances and approvals
Biodermis Corp. has 5 FDA 510(k) clearances (first 1994, latest 2001), across 2 product codes in 1 review panel. Median 510(k) review time: 39 days.
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 |
|---|---|---|---|
| MDA | Elastomer, Silicone, For Scar Management | 4 | 4 |
| GEH | Unit, Cryosurgical, Accessories | 1 | 1 |
Review panels
Most recent Biodermis Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003948 | EPI-DERM SILICONE GEL SHEETING | MDA | 2001-01-29 | 39 |
| K992146 | SCARAID SILICONE GEL SHEETING | MDA | 1999-07-30 | 36 |
| K991604 | EPI-FOAM SILICONE SHEETING | MDA | 1999-06-09 | 30 |
| K964047 | CRYOSIL SILICONE GEL SHEETING | GEH | 1997-03-19 | 161 |
| K942156 | EPI-DERM SILICONE GEL SHEETING | MDA | 1994-06-13 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Biodermis Corp..
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 Biodermis Corp. have?
Biodermis Corp. has 5 FDA 510(k) clearances (first 1994, latest 2001), across 2 product codes in 1 review panel.
How long does FDA take to clear Biodermis Corp.'s 510(k)s?
The median time from FDA receipt to decision across Biodermis Corp.'s cleared 510(k)s is 39 days.
What devices does Biodermis Corp. make?
Its most frequent FDA product codes are MDA (Elastomer, Silicone, For Scar Management, 4); GEH (Unit, Cryosurgical, Accessories, 1).
Has Biodermis Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Biodermis Corp. Related entities may recall under other names.
Next steps
- See all 5 Biodermis Corp. clearances with predicates and recalls
- Run predicate analysis for product code MDA, Biodermis Corp.'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.