510(k) Report

FDA applicant

Cardio-Dynamics Laboratories, Inc.

Mchenry, IL4 decisions1977–19780 recalls

FDA records 4 decisions for Cardio-Dynamics Laboratories, Inc. (Mchenry, IL) from 1977 to 1978: 4 510(k) clearances. Most are in product codes DRX (Electrode, Electrocardiograph) and DSI (Detector And Alarm, Arrhythmia). 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 Cardio-Dynamics Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardio-Dynamics Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardio-Dynamics Laboratories, Inc. 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?

  • DRXElectrode, Electrocardiograph2decisions
  • DSIDetector And Alarm, Arrhythmia1decision
  • DSMAlarm, Leakage Current, Portable1decision

What has FDA decided for it lately?

  • K781911Ecg Analyzer, High SpeedCardio-Dynamics Laboratories, Inc. · 1978
  • K781514Ecg Electrode, 2021, 2022, 2032, 2033Cardio-Dynamics Laboratories, Inc. · 1978
  • K781152Electrocardiographic Ecg RecorderCardio-Dynamics Laboratories, Inc. · 1978
  • K770988Foam Ecg Electrode, 2060 and 2061Cardio-Dynamics Laboratories, Inc. · 1977

All 4 as Cardio-Dynamics Laboratories, Inc. →