510(k) Report

FDA applicant

Eurospital S.P.A.

Trieste, IT5 decisions2000–20190 recalls

FDA records 5 decisions for Eurospital S.P.A. (Trieste, IT) from 2000 to 2019: 5 510(k) clearances. Most are in product codes NXO (Calprotectin, Fecal) and LHI (Set, I.V. Fluid Transfer). Its devices cite 4 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Eurospital”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

How often FDA has decided Eurospital S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2014: 12016: 12019: 2
2007high 2 (2019) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Eurospital S.P.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?

  • NXOCalprotectin, Fecal4decisions
  • LHISet, I.V. Fluid Transfer1decision

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K160447Calprest NGEurospital S.P.A. · 20164cite it
  • K130945CalprestEurospital S.P.A. · 20142cite it

What has FDA decided for it lately?

  • K191589Calprest, EasyCalEurospital S.P.A. · 2019
  • K191592CalprestNG, EasyCalEurospital S.P.A. · 2019
  • K160447Calprest NGEurospital S.P.A. · 2016
  • K130945CalprestEurospital S.P.A. · 2014
  • K000367SecurmixEurospital · 2000

All 4 as Eurospital S.P.A. →The one decision as Eurospital →