510(k) Report

FDA applicant

H&C Medical Devices Spa

Milan, IT3 decisions2000–20020 recalls

FDA records 3 decisions for H&C Medical Devices Spa (Milan, IT) from 2000 to 2002: 3 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and DXH (Transmitters And Receivers…). Its devices cite 1 predicate, 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 H&C Medical Devices Spa’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for H&C Medical Devices Spa since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — H&C Medical Devices Spa 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
  • DXHTransmitters And Receivers, Electrocardiograph, Telephone1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K002074AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View HesH&C Medical Devices Spa · 20004cite it
  • K012012Ecg HomeH&C Medical Devices Spa · 20021cites it

What has FDA decided for it lately?

  • K012012Ecg HomeH&C Medical Devices Spa · 2002
  • K010822AB Cardiette Start 200 HVH&C Medical Devices Spa · 2001
  • K002074AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View HesH&C Medical Devices Spa · 2000

All 3 as H&C Medical Devices Spa →