510(k) Report

FDA applicant

Cardionetics, Ltd.

Waltham, MA1 decision2001–20010 recalls

FDA records 1 decision for Cardionetics, Ltd. (Waltham, MA) in 2001: 1 510(k) clearance. All are in product code MLO (Electrocardiograph, Ambulatory, With Analysis…). 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 Cardionetics, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardionetics, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardionetics, Ltd. 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?

  • MLOElectrocardiograph, Ambulatory, With Analysis Algorithm1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K010396C. NET 2100Cardionetics, Ltd. · 20011cites it

What has FDA decided for it lately?

  • K010396C. NET 2100Cardionetics, Ltd. · 2001

The one decision as Cardionetics, Ltd. →