FDA applicant

Cardio Data

Mchenry, IL6 decisions1977–19850 recalls

FDA records 6 decisions for Cardio Data (Mchenry, IL) from 1977 to 1985: 6 510(k) clearances. Most are in product codes DSH (Recorder, Magnetic Tape, Medical) 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 Data’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardio Data since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardio Data by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Cardio Data

Which product codes does it file in?

What has FDA decided for it lately?