510(k) Report

FDA applicant

Remco Italia S.P.A.

South Pedrino Di Vignate, Mi., IT3 decisions1985–20030 recalls

FDA records 3 decisions for Remco Italia S.P.A. (South Pedrino Di Vignate, Mi., IT) from 1985 to 2003: 3 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and MWJ (Electrocardiograph, Ambulatory (Without…). Its devices cite 4 predicates, 0 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 Remco Italia S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Remco Italia S.P.A. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Remco Italia 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?

  • DPSElectrocardiograph2decisions
  • MWJElectrocardiograph, Ambulatory (Without Analysis)1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K032200Elan Digital 12 Channel ElectrocardiographRemco Italia S.P.A. · 20033cite it

What has FDA decided for it lately?

  • K032200Elan Digital 12 Channel ElectrocardiographRemco Italia S.P.A. · 2003
  • K032276Click HolterRemco Italia S.P.A. · 2003
  • K852770Carioline (Electrocardiograph)Remco Italia S.P.A. · 1985

All 3 as Remco Italia S.P.A. →