510(k) Report

FDA applicant

San UP S.A.

Great Neck, NY2 decisions2001–20010 recalls

FDA records 2 decisions for San UP S.A. (Great Neck, NY) in 2001: 2 510(k) clearances. Most are in product codes BTI (Compressor, Air, Portable) and 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 San UP S.A.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for San UP S.A. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — San UP S.A. 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?

  • BTICompressor, Air, Portable1decision
  • CAFNebulizer (Direct Patient Interface)1decision

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.

  • K002468San UP S.a. Nebulizer Compressor, with Disposable Nebulizer, Model 3050San UP S.A. · 20011cites it

What has FDA decided for it lately?

  • K002543Comoact Ultrasonic Nebulizer, Model 3060San UP S.A. · 2001
  • K002468San UP S.a. Nebulizer Compressor, with Disposable Nebulizer, Model 3050San UP S.A. · 2001

All 2 as San UP S.A. →