510(k) Report

FDA applicant

Les Laboratorires Brothier, S.A.

St Louis, MO5 decisions1990–20040 recalls

FDA records 5 decisions for Les Laboratorires Brothier, S.A. (St Louis, MO) from 1990 to 2004: 5 510(k) clearances. Most are in product codes EMX (Balloon, Epistaxis) and QSY (Hemostatic Wound Dressing Without Thrombin Or…). Its devices cite 6 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Les Laboratorires Brothier, S.A.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Les Laboratorires Brothier, S.A. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Les Laboratorires Brothier, S.A. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Les Laboratorires Brothier, S.A.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • EMXBalloon, Epistaxis2decisions
  • QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics1decision
  • KMFBandage, Liquid1decision
  • FRODressing, Wound, Drug1decision

Whose devices does it build on?

Its devices cite 6 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K984069Entaxis Nasal PackingLes Laboratorires Brothier, S.A. · 19994cite it
  • K922540Wound DressingLes Laboratorires Brothier, S.A. · 19922cite it
  • K041446NasalceaseLes Laboratorires Brothier, S.A. · 20041cites it
  • K905314Algoderm Alginate Wound DressingLes Laboratorires Brothier, S.A. · 19911cites it

What has FDA decided for it lately?

  • K041446NasalceaseLes Laboratorires Brothier, S.A. · 2004
  • K984069Entaxis Nasal PackingLes Laboratorires Brothier, S.A. · 1999
  • K922540Wound DressingLes Laboratorires Brothier, S.A. · 1992
  • K905314Algoderm Alginate Wound DressingLes Laboratorires Brothier, S.A. · 1991
  • K893123Adhesive Bandages & Pads for Minor Cuts/ScrapesLes Laboratorires Brothier, S.A. · 1990

All 5 as Les Laboratorires Brothier, S.A. →