510(k) Report

FDA applicant

Cardio Command

Tampa1 decision1986–19863 recalls

FDA records 1 decision for Cardio Command (Tampa) in 1986: 1 original PMA approval. All are in product code LPA (System, Esophageal Pacing). 3 recalls are 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 Cardio Command’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardio Command since 2007.

Recalls per year

1in 2019

2010: 22019: 1
2007high 2 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cardio Command 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?

  • LPASystem, Esophageal Pacing1decision

What has FDA decided for it lately?

  • P860008Arzco Transesophageal Cardiac Stimulator Model 7Cardio Command · 19863 recalls

The one decision as Cardio Command →

What has been recalled?

3 recalls linked to its devices; the latest:

  • P860008CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF…May 10, 2019Class III
  • P860008***REF #200***TAPSCOPE 550. Each pouch contains one (1) 18 French esophageal stethoscope…Oct 25, 2010
  • P860008***REF #250***TAPSCOPE 550F. Each pouch contains one (1) 18 French esophageal…Oct 25, 2010