Bioderm, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Bioderm, Inc.” (first 1987, latest 1999), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 68 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 | 7 | 7 |
| MGP | Dressing, Wound And Burn, Occlusive | 3 | 3 |
| FRO | Dressing, Wound, Drug | 2 | 2 |
| EXI | Device, Paste-On For Incontinence, Sterile | 1 | 1 |
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | 1 | 1 |
Review panels
Most recent Bioderm, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990955 | MODIFICATION OF:BIODERM FOAM WOUND DRESSING | KMF | 1999-05-18 | 57 |
| K982778 | BIODERM FOAM WOUND DRESSING | KMF | 1998-10-21 | 75 |
| K982939 | BTF THIN FILM WOUND DRESSING | MGP | 1998-10-13 | 53 |
| K980451 | BIODERM CALCIUM ALGINATE DRESSING | KMF | 1998-04-09 | 63 |
| K973429 | BIODERM FOAM WOUND DRESSING | KMF | 1997-12-01 | 82 |
| K963950 | BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE | EXI | 1997-01-10 | 100 |
| K963602 | BIODERM PVP FOAM WOUND DRESSING | KMF | 1996-10-30 | 51 |
| K951166 | BIODERM MEDICAL HYDROGEL ISLAND DRESSING | NAE | 1995-06-21 | 99 |
| K951842 | BIODERM MEDICAL TRANSPARENT FILM DRESSING | MGP | 1995-06-12 | 53 |
| K950685 | BIODERM MEDICAL HYDROCOLLOID WOUND DRESSING | KMF | 1995-06-09 | 115 |
4 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2011-05-31.
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.
- Bioderm Sciences, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bioderm, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Bioderm, Inc.” (first 1987, latest 1999), across 5 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 Bioderm, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bioderm, Inc. is 68 days.
Which FDA product codes appear under Bioderm, Inc.?
The most frequent FDA product codes under this applicant name are KMF (Bandage, Liquid, 7); MGP (Dressing, Wound And Burn, Occlusive, 3); FRO (Dressing, Wound, Drug, 2).
Next steps
- See all 14 Bioderm, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KMF, Bioderm, 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.