510(k) Report

FDA applicant

Eurosets S.R.L

Medolla, IT7 decisions2011–20260 recalls

FDA records 7 decisions for Eurosets S.R.L (Medolla, IT) from 2011 to 2026: 7 510(k) clearances. All are in product code DTZ (Oxygenator, Cardiopulmonary Bypass). Since 2016 its 510(k)s took a median of 239 days from receipt to decision, against 336 for FDA’s reviews in the same codes and years. Its devices cite 12 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, cardiovascular panel, where it files most

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

FDA decisions per year

2in 2025

2011: 12015: 12021: 22025: 22026 (partial year): 1
2011high 2 (2021) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Eurosets S.R.L by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DTZOxygenator, Cardiopulmonary Bypass7decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 239 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 336 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K141492Advanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile)Eurosets S.R.L · 20152cite it
  • K102109Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg Venous Cardiotomy Resevoir 4500 Model…Eurosets S.R.L · 20111cites it
  • K202206AMG PMP PediatricEurosets S.R.L · 20211cites it

What has FDA decided for it lately?

  • K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.L · 2026
  • K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus…Eurosets S.R.L · 2025
  • K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.L · 2025
  • K202510AMG PMP InfantEurosets S.R.L · 2021
  • K202206AMG PMP PediatricEurosets S.R.L · 2021
  • K141492Advanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile)Eurosets S.R.L · 2015
  • K102109Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg Venous Cardiotomy Resevoir 4500 Model…Eurosets S.R.L · 2011

All 7 as Eurosets S.R.L →