510(k) Report

FDA applicant

Qcare International, LLC

Marietta1 decision2000–20000 recalls

FDA records 1 decision for Qcare International, LLC (Marietta) in 2000: 1 original PMA approval. All are in product code MTV (Sharps Needle Destruction Device). 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, general hospital panel, where it files most

How often FDA has decided Qcare International, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Qcare International, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Qcare International, 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?

  • MTVSharps Needle Destruction Device1decision

What has FDA decided for it lately?

  • P980020Q 103 Needle Management SystemQcare International, LLC · 2000

The one decision as Qcare International, LLC →