510(k) Report

FDA applicant

Cardiac Designs, LLC

Monroe, CT3 decisions2013–20170 recalls

FDA records 3 decisions for Cardiac Designs, LLC (Monroe, CT) from 2013 to 2017: 3 510(k) clearances. Most are in product codes DXH (Transmitters And Receivers…) and DQK (Computer, Diagnostic, Programmable). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Cardiac Designs, Inc.”.

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 Cardiac Designs, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2013: 22017: 1
2013high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Cardiac Designs, LLC by year, 2013–2026Sources: 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, Telephone2decisions
  • DQKComputer, Diagnostic, Programmable1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K122184Ecg CheckCardiac Designs, LLC · 20132cite it

What has FDA decided for it lately?

  • K170506ECG Check - Universal, ECG Check - Universal PlusCardiac Designs, Inc. · 2017
  • K131045Enterprise Ecg Analysis / Interpretation SoftwareCardiac Designs, LLC · 2013
  • K122184Ecg CheckCardiac Designs, LLC · 2013

All 2 as Cardiac Designs, LLC →The one decision as Cardiac Designs, Inc. →