510(k) Report

FDA applicant

Arzco Medical Electronics, Inc.

Vernon Hills, IL3 decisions1991–19910 recalls

FDA records 3 decisions for Arzco Medical Electronics, Inc. (Vernon Hills, IL) in 1991: 3 510(k) clearances. Most are in product codes DRF (Catheter, Electrode Recording, Or Probe…) and BZT (Stethoscope, Esophageal, With Electrical…). 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 Arzco Medical Electronics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Arzco Medical Electronics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Arzco Medical Electronics, 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?

  • DRFCatheter, Electrode Recording, Or Probe, Electrode Recording2decisions
  • BZTStethoscope, Esophageal, With Electrical Conductors1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K905831Arzco Octapolar Esophageal Cardiac Record CathArzco Medical Electronics, Inc. · 19911cites it
  • K903136Arzo Tapcath Esophageal Recording CatheterArzco Medical Electronics, Inc. · 19911cites it

What has FDA decided for it lately?

  • K904943Tapscope Esophageal Cardiac Recording StethoscopeArzco Medical Electronics, Inc. · 1991
  • K905831Arzco Octapolar Esophageal Cardiac Record CathArzco Medical Electronics, Inc. · 1991
  • K903136Arzo Tapcath Esophageal Recording CatheterArzco Medical Electronics, Inc. · 1991

All 3 as Arzco Medical Electronics, Inc. →