510(k) Report

FDA applicant

Arrhythmia Technologies, Inc.

San Jose, CA2 decisions1992–19920 recalls

FDA records 2 decisions for Arrhythmia Technologies, Inc. (San Jose, CA) in 1992: 2 510(k) clearances. All are in product code DRF (Catheter, Electrode Recording, Or Probe…). 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 Arrhythmia Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Arrhythmia Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Arrhythmia Technologies, 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

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K915563Diagnostic EP CatheterArrhythmia Technologies, Inc. · 19921cites it

What has FDA decided for it lately?

  • K915563Diagnostic EP CatheterArrhythmia Technologies, Inc. · 1992
  • K915640Voyagr Series of Deflectable Diagostic EP CatheterArrhythmia Technologies, Inc. · 1992

All 2 as Arrhythmia Technologies, Inc. →