510(k) Report

FDA applicant

Cardiocalm Srl

Montichiari, IT3 decisions2020–20250 recalls

FDA records 3 decisions for Cardiocalm Srl (Montichiari, IT) from 2020 to 2025: 3 510(k) clearances. Most are in product codes DQK (Computer, Diagnostic, Programmable) and MLO (Electrocardiograph, Ambulatory, With Analysis…). Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Cardiocalm”.

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 Cardiocalm Srl’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2020: 12022: 12025: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Cardiocalm Srl by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DQKComputer, Diagnostic, Programmable2decisions
  • MLOElectrocardiograph, Ambulatory, With Analysis Algorithm1decision

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K213861CER-SCardiocalm Srl · 20221cites it
  • K193177CER-SCardiocalm · 20201cites it

What has FDA decided for it lately?

All 2 as Cardiocalm Srl →The one decision as Cardiocalm →