510(k) Report

FDA applicant

Heart Check Systems, Inc.

Mchenry, IL1 decision1981–19810 recalls

FDA records 1 decision for Heart Check Systems, Inc. (Mchenry, IL) in 1981: 1 510(k) clearance. All are in product code DXH (Transmitters And Receivers…). 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 Heart Check Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Heart Check Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Heart Check Systems, 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?

  • DXHTransmitters And Receivers, Electrocardiograph, Telephone1decision

What has FDA decided for it lately?

  • K810608Transmitter & Receivers, Telephone, ElecHeart Check Systems, Inc. · 1981

The one decision as Heart Check Systems, Inc. →

Other applicant names beginning “Heart”

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

The Heart Valve Div. Medtronic Cardiovascular Surg 5Heart Sync, Inc. 5Heart Technology, Inc. 4Heart Technology Mfg., Inc. 3Heart Imaging Technologies, LLC 2Heart Alert, Inc. 1Heart Sounds, Inc. 1Heart Rate, Inc. 1Heart Rhythm Technologies, Inc. 1