510(k) Report

FDA applicant

Sim Italia S.R.L.

Great Neck,, NY3 decisions1996–20030 recalls

FDA records 3 decisions for Sim Italia S.R.L. (Great Neck,, NY) from 1996 to 2003: 3 510(k) clearances. All are in product code CAW (Generator, Oxygen, Portable). Its devices cite 6 predicates, 3 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Sim Italia S.R.L. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sim Italia 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?

  • CAWGenerator, Oxygen, Portable3decisions

Whose devices does it build on?

Its devices cite 6 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 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.

  • K963042Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 19963cite it
  • K971947Innosan Travelair S Plus Portable Oxygen Concentrator, Code NO. M407001853 (with AC Power Supply Accessory)Sim Italia S.R.L. · 19972cite it

What has FDA decided for it lately?

  • K030233Travelsome StandardSim Italia S.R.L. · 2003
  • K971947Innosan Travelair S Plus Portable Oxygen Concentrator, Code NO. M407001853 (with AC Power Supply Accessory)Sim Italia S.R.L. · 1997
  • K963042Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 1996

All 3 as Sim Italia S.R.L. →