510(k) Report

FDA applicant

Cardiodata Corp.

Northborough, MA4 decisions1986–19900 recalls

FDA records 4 decisions for Cardiodata Corp. (Northborough, MA) from 1986 to 1990: 4 510(k) clearances. Most are in product codes DSI (Detector And Alarm, Arrhythmia) and DSH (Recorder, Magnetic Tape, Medical). 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 Cardiodata Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardiodata Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardiodata Corp. 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?

  • DSIDetector And Alarm, Arrhythmia3decisions
  • DSHRecorder, Magnetic Tape, Medical1decision

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.

  • K900607MK5 Detector & Alarm, Arrhythmia W/Software 2.11Cardiodata Corp. · 19901cites it

What has FDA decided for it lately?

  • K900607MK5 Detector & Alarm, Arrhythmia W/Software 2.11Cardiodata Corp. · 1990
  • K881488Holter ScannerCardiodata Corp. · 1988
  • K873337Model SSR1 Holter MonitorCardiodata Corp. · 1987
  • K860167Prodigy and Prodigy PlusCardiodata Corp. · 1986

All 4 as Cardiodata Corp. →