510(k) Report

FDA applicant

Cardiorhythm

San Jose, CA2 decisions1993–19930 recalls

FDA records 2 decisions for Cardiorhythm (San Jose, CA) in 1993: 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 Cardiorhythm’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardiorhythm since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardiorhythm 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 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.

  • K923915Torqr Series Diagnostic EP CathetersCardiorhythm · 19932cite it

What has FDA decided for it lately?

  • K923916Voyagr Series Diagnostic EP CathetersCardiorhythm · 1993
  • K923915Torqr Series Diagnostic EP CathetersCardiorhythm · 1993

All 2 as Cardiorhythm →