Medi-Trace Combination Defibrillation & ECG Electrode for Laerdal

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K955923 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the Medi-Trace Combination Defibrillation & ECG Electrode, and who is it intended for?

  The Medi-Trace Combination Defibrillation & ECG Electrode is designed for simultaneous defibrillation and ECG monitoring, enabling rapid assessment and treatment of cardiac arrest or arrhythmias in emergency settings. It is specifically intended for professional healthcare providers and first responders, as it combines two critical functions into a single-use adhesive electrode.

• Is this electrode reusable, or is it meant for single-use only?

  This electrode is explicitly labeled as single-use, meaning it is intended for one-time application only. This design ensures sterility and reduces the risk of cross-contamination in emergency medical scenarios.

• How should the Medi-Trace Combination Defibrillation & ECG Electrode be stored, and what sterility guarantees does it provide?

  The electrode is supplied sterile and packaged individually, so no special storage conditions are required beyond protecting it from contamination. The sterile packaging ensures it remains uncontaminated until use, making it safe for immediate application in emergency situations.

• Which defibrillators is this electrode compatible with, and how does that affect its use?

  The Medi-Trace Combination Defibrillation & ECG Electrode is specifically designed for compatibility with Laerdal defibrillators. This targeted compatibility ensures seamless integration with these devices, allowing healthcare providers and first responders to rely on it for accurate ECG monitoring and effective defibrillation during cardiac emergencies.

• What regulatory pathway was followed for this device’s approval, and what does that mean for its use?

  The device received FDA 510(k) clearance (K955923) under a traditional review pathway, with a decision of *Substantially Equivalent* to a predicate device. This means its safety and performance were compared to an existing approved device, and it was determined to be equivalent in terms of technological characteristics. The clearance confirms it meets FDA standards for use in defibrillation and ECG monitoring.