510(k) Report

FDA applicant

Cardiodyne General, Inc.

Mchenry, IL2 decisions1981–19830 recalls

FDA records 2 decisions for Cardiodyne General, Inc. (Mchenry, IL) from 1981 to 1983: 2 510(k) clearances. Most are in product codes DSK (Computer, Blood-Pressure) and DXN (System, Measurement, Blood-Pressure…). 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 Cardiodyne General, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardiodyne General, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardiodyne General, 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?

  • DSKComputer, Blood-Pressure1decision
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive1decision

What has FDA decided for it lately?

  • K830184Sphygmolog II Model DCardiodyne General, Inc. · 1983
  • K811079SyphgmologCardiodyne General, Inc. · 1981

All 2 as Cardiodyne General, Inc. →

Other applicant names beginning “Cardiodyne”

FDA records each applicant name separately; these may or may not be the same firm.

Cardiodyne, Inc. 3