510(k) Report

FDA applicant

Silvestrin Fabris S.R.L.

Buenos Aires, AR1 decision2005–20050 recalls

FDA records 1 decision for Silvestrin Fabris S.R.L. (Buenos Aires, AR) in 2005: 1 510(k) clearance. All are in product code CAF (Nebulizer (Direct Patient Interface)). 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, anesthesiology panel, where it files most

How often FDA has decided Silvestrin Fabris S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Silvestrin Fabris S.R.L. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Silvestrin Fabris S.R.L. 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?

  • CAFNebulizer (Direct Patient Interface)1decision

What has FDA decided for it lately?

  • K050183Silfab Super 2 Max Compressor, N28 SeriesSilvestrin Fabris S.R.L. · 2005

The one decision as Silvestrin Fabris S.R.L. →