510(k) Report

FDA applicant

Cardiocom, LLC

Deer Field, IL5 decisions2004–20120 recalls

FDA records 5 decisions for Cardiocom, LLC (Deer Field, IL) from 2004 to 2012: 5 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and DRG (Transmitters And Receivers, Physiological…). Its devices cite 7 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Cardiocom”.

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

FDA decisions per year

1in 2012

2009: 12012: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cardiocom, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive4decisions
  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency1decision

Whose devices does it build on?

Its devices cite 7 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 3 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.

  • K053303Cardiocom Commander IiiCardiocom, LLC · 20053cite it
  • K122285Tablet CommanderCardiocom, LLC · 20122cite it
  • K043096Commander IICardiocom · 20041cites it
  • K053304Commander Iii Non-Invasive Blood Pressure SystemCardiocom, LLC · 20051cites it
  • K091821Commander 111, Model CD300-CD399Cardiocom, LLC · 20091cites it

What has FDA decided for it lately?

  • K122285Tablet CommanderCardiocom, LLC · 2012
  • K091821Commander 111, Model CD300-CD399Cardiocom, LLC · 2009
  • K053303Cardiocom Commander IiiCardiocom, LLC · 2005
  • K053304Commander Iii Non-Invasive Blood Pressure SystemCardiocom, LLC · 2005
  • K043096Commander IICardiocom · 2004

All 4 as Cardiocom, LLC →The one decision as Cardiocom →