510(k) Report

FDA applicant

Dr. Len'S Medical Products, LLC

Alpharetta, GA1 decision2004–20040 recalls

FDA records 1 decision for Dr. Len'S Medical Products, LLC (Alpharetta, GA) in 2004: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 2 predicates, 0 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

How often FDA has decided Dr. Len'S Medical Products, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dr. Len'S Medical Products, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dr. Len'S Medical Products, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dr. Len'S Medical Products, LLC’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?

  • FRODressing, Wound, Drug1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K033164Abram's Multi-Density Polyurethane Foam Wound Dressing SystemDr. Len'S Medical Products, LLC · 2004

The one decision as Dr. Len'S Medical Products, LLC →