Les Laboratorires Brothier, S.A.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Les Laboratorires Brothier, S.A.” (first 1990, latest 2004), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 83 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 |
|---|---|---|---|
| EMX | Balloon, Epistaxis | 2 | 2 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| KMF | Bandage, Liquid | 1 | 1 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | 1 | 1 |
Review panels
Most recent Les Laboratorires Brothier, S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041446 | NASALCEASE | EMX | 2004-07-01 | 30 |
| K984069 | ENTAXIS NASAL PACKING | EMX | 1999-01-25 | 70 |
| K922540 | WOUND DRESSING | KMF | 1992-08-24 | 87 |
| K905314 | ALGODERM ALGINATE WOUND DRESSING | FRO | 1991-02-19 | 83 |
| K893123 | ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES | QSY | 1990-02-13 | 294 |
Recalls
openFDA lists no recalls under a recalling firm named Les Laboratorires Brothier, S.A..
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 Les Laboratorires Brothier, S.A.?
FDA lists 5 510(k) clearances under the applicant name “Les Laboratorires Brothier, S.A.” (first 1990, latest 2004), across 4 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 Les Laboratorires Brothier, S.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Les Laboratorires Brothier, S.A. is 83 days.
Which FDA product codes appear under Les Laboratorires Brothier, S.A.?
The most frequent FDA product codes under this applicant name are EMX (Balloon, Epistaxis, 2); FRO (Dressing, Wound, Drug, 1); KMF (Bandage, Liquid, 1).
Next steps
- See all 5 Les Laboratorires Brothier, S.A. clearances with predicates and recalls
- Run predicate analysis for product code EMX, Les Laboratorires Brothier, S.A.'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.