Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Les Laboratorires Brothier, S.A. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
294 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041446 | NASALCEASE | Les Laboratorires Brothier, S.A. | 2004-07-01 | 30 | 0 |
| K984069 | ENTAXIS NASAL PACKING | Les Laboratorires Brothier, S.A. | 1999-01-25 | 70 | 0 |
| K922540 | WOUND DRESSING | Les Laboratorires Brothier, S.A. | 1992-08-24 | 87 | 0 |
| K905314 | ALGODERM ALGINATE WOUND DRESSING | Les Laboratorires Brothier, S.A. | 1991-02-19 | 83 | 0 |
| K893123 | ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES | Les Laboratorires Brothier, S.A. | 1990-02-13 | 294 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda