510(k) Report

FDA applicant

Quality Medical Solusions, LLC

Alpharetta, GA1 decision2002–20020 recalls

FDA records 1 decision for Quality Medical Solusions, LLC (Alpharetta, GA) in 2002: 1 510(k) clearance. All are in product code HDY (Dilator, Cervical, Hygroscopic-Laminaria). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Quality Medical Solusions, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Quality Medical Solusions, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Quality Medical Solusions, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HDYDilator, Cervical, Hygroscopic-Laminaria1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K021012Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MMQuality Medical Solusions, LLC · 20021cites it

What has FDA decided for it lately?

  • K021012Laminaria 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MMQuality Medical Solusions, LLC · 2002

The one decision as Quality Medical Solusions, LLC →