510(k) Report

FDA applicant

Grandcor Medical Systems

Dayton, OH8 decisions1986–19910 recalls

FDA records 8 decisions for Grandcor Medical Systems (Dayton, OH) from 1986 to 1991: 8 510(k) clearances. Most are in product codes DSI (Detector And Alarm, Arrhythmia) and ISD (Exerciser, Measuring). 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 Grandcor Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Grandcor Medical Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Grandcor Medical Systems 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, Arrhythmia4decisions
  • ISDExerciser, Measuring1decision
  • BZCCalculator, Pulmonary Function Data1decision
  • DRXElectrode, Electrocardiograph1decision
  • DPSElectrocardiograph1decision

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.

  • K864260Applicard System (Ecg Electrode System)Grandcor Medical Systems · 19872cite it

What has FDA decided for it lately?

  • K905480SpiroscopeGrandcor Medical Systems · 1991
  • K895547Grandcor/Cardioline Ect Stress TestingGrandcor Medical Systems · 1990
  • K883410Cardiomega-TGrandcor Medical Systems · 1988
  • K871890Cardio-Mega SystemGrandcor Medical Systems · 1987
  • K864260Applicard System (Ecg Electrode System)Grandcor Medical Systems · 1987
  • K864978AppliscopeGrandcor Medical Systems · 1987
  • K864581ApplidynGrandcor Medical Systems · 1987
  • K862375Cardio Port 500 24-H Ecg Ambulatory Monitor SystemGrandcor Medical Systems · 1986

All 8 as Grandcor Medical Systems →