Dermaphylyx, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Dermaphylyx, Inc.” (first 1999, latest 1999), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 71 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 |
|---|---|---|---|
| KMF | Bandage, Liquid | 4 | 4 |
| MGP | Dressing, Wound And Burn, Occlusive | 3 | 3 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | 1 | 1 |
Review panels
Most recent Dermaphylyx, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992302 | DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS | MGP | 1999-09-14 | 68 |
| K991920 | DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING | KMF | 1999-08-12 | 66 |
| K991933 | DERMAPHYLYX FOAM ISLAND DRESSING | KMF | 1999-07-30 | 52 |
| K991609 | DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING | KMF | 1999-07-20 | 71 |
| K991608 | DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING | KMF | 1999-07-20 | 71 |
| K991061 | DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING | NAE | 1999-06-28 | 90 |
| K990891 | DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING | FRO | 1999-05-27 | 71 |
| K990875 | DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING | MGP | 1999-05-27 | 72 |
| K990438 | DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING | MGP | 1999-03-25 | 42 |
Recalls
openFDA lists no recalls under a recalling firm named Dermaphylyx, 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 Dermaphylyx, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Dermaphylyx, Inc.” (first 1999, latest 1999), across 4 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 Dermaphylyx, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dermaphylyx, Inc. is 71 days.
Which FDA product codes appear under Dermaphylyx, Inc.?
The most frequent FDA product codes under this applicant name are KMF (Bandage, Liquid, 4); MGP (Dressing, Wound And Burn, Occlusive, 3); FRO (Dressing, Wound, Drug, 1).
Next steps
- See all 9 Dermaphylyx, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KMF, Dermaphylyx, 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.