510(k) Report

FDA applicant

Medicotest A/S

Washington, DC7 decisions1997–20020 recalls

FDA records 7 decisions for Medicotest A/S (Washington, DC) from 1997 to 2002: 7 510(k) clearances. Most are in product codes IKT (Electrode, Needle, Diagnostic Electromyograph) and DRX (Electrode, Electrocardiograph). 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, physical medicine panel, where it files most

How often FDA has decided Medicotest A/S’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medicotest A/S since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medicotest A/S 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?

  • IKTElectrode, Needle, Diagnostic Electromyograph3decisions
  • DRXElectrode, Electrocardiograph2decisions
  • MKJAutomated External Defibrillators (Non-Wearable)1decision
  • GXYElectrode, Cutaneous1decision

Who builds on its devices?

Later devices cite its devices 8 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.

  • K973529Neuroline, Disposable Concentric Needle ElectrodesMedicotest A/S · 19975cite it
  • K001869Diagnostic Electromyography Needle Electrode, Disposable Hypodermic NeedleMedicotest A/S · 20002cite it
  • K983689Blue Sensor Supatab,Disposable Ecg ElectrodesMedicotest A/S · 19991cites it

What has FDA decided for it lately?

  • K020382Blue Sensor, Disposable Ecg Electrodes for AnaesthesiaMedicotest A/S · 2002
  • K020907Neuroline, Subdermal Needle ElectrodesMedicotest A/S · 2002
  • K002079Multi-Function Defibrillation ElectrodeMedicotest A/S · 2001
  • K001869Diagnostic Electromyography Needle Electrode, Disposable Hypodermic NeedleMedicotest A/S · 2000
  • K983689Blue Sensor Supatab,Disposable Ecg ElectrodesMedicotest A/S · 1999
  • K973529Neuroline, Disposable Concentric Needle ElectrodesMedicotest A/S · 1997
  • K965194Medicom, Tens ElectrodesMedicotest A/S · 1997

All 7 as Medicotest A/S →

Other applicant names beginning “Medicotest”

FDA records each applicant name separately; these may or may not be the same firm.

Medicotest, Inc. 14