510(k) Report

FDA applicant

Dks Loversan Industria Biomedica Spa

Appollo Beach, FL1 decision2005–20050 recalls

FDA records 1 decision for Dks Loversan Industria Biomedica Spa (Appollo Beach, FL) in 2005: 1 510(k) clearance. All are in product code FPA (Set, Administration, Intravascular). Its devices cite 3 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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Dks Loversan Industria Biomedica Spa’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dks Loversan Industria Biomedica Spa since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dks Loversan Industria Biomedica Spa 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?

  • FPASet, Administration, Intravascular1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K043328Microflo-Safe Scalp Vein SetDks Loversan Industria Biomedica Spa · 2005

The one decision as Dks Loversan Industria Biomedica Spa →