510(k) Report

FDA applicant

Cardiocommand, Inc.

Tampa1 decision1986–19861 recall

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

FDA decisions per year

No FDA decision for Cardiocommand, Inc. since 2007.

Recalls per year

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cardiocommand, 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?

  • LPASystem, Esophageal Pacing1decision

What has FDA decided for it lately?

  • P840002Stat-Pace IICardiocommand, Inc. · 19861 recall

The one decision as Cardiocommand, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • P840002TAPSYSTEM Model 2A, REF 8002AJun 24, 2019Class III