510(k) Report

FDA applicant

Med2000 S.R.L.

Great Neck, NY3 decisions2004–20040 recalls

FDA records 3 decisions for Med2000 S.R.L. (Great Neck, NY) in 2004: 3 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and BTI (Compressor, Air, Portable). Its devices cite 6 predicates, 2 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 Med2000 S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Med2000 S.R.L. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Med2000 S.R.L. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Med2000 S.R.L.’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?

  • CAFNebulizer (Direct Patient Interface)2decisions
  • BTICompressor, Air, Portable1decision

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K031908MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and MED2000 Spa Nebulizer, Model A1/C…Med2000 S.R.L. · 20043cite it

What has FDA decided for it lately?

  • K041974MED2000 Nebulizer Compressor, Models P3, P4, P5 with NebulizerMed2000 S.R.L. · 2004
  • K041327MED2000 Spa Nebulizer Andyflow, Model A1/C with AccessoriesMed2000 S.R.L. · 2004
  • K031908MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and MED2000 Spa Nebulizer, Model A1/C…Med2000 S.R.L. · 2004

All 3 as Med2000 S.R.L. →