Medi-Trace 1310P Combination Defibrillation, Monitoring & Pacing Electrode

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

510(k) Number

K980857 ↗

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 types of emergencies is the Medi-Trace 1310P designed to address in pre-hospital and clinical settings?

  The Medi-Trace 1310P is specifically designed for cardiac emergencies requiring defibrillation, ECG monitoring, and temporary cardiac pacing. It is intended for use during cardiac arrest scenarios or bradycardia events where immediate intervention is critical, enabling comprehensive cardiac assessment and intervention through a single electrode system.

• Is the Medi-Trace 1310P reusable or intended for single-use, and how should it be stored to maintain sterility?

  The Medi-Trace 1310P is a single-use, sterile electrode. To maintain sterility and functionality, storage and handling must strictly follow the manufacturer’s guidelines, ensuring it remains ready for immediate use in emergencies without compromising its sterile state.

• What regulatory pathway was followed for FDA clearance of the Medi-Trace 1310P, and what classification does it hold?

  The Medi-Trace 1310P underwent a traditional 510(k) clearance process and was determined to be substantially equivalent to a predicate device. It is classified as a Class III medical device under FDA regulations (870.5310), reflecting its critical role in life-saving cardiac interventions.

• Can this device be used with any automated external defibrillator (non-wearable), or is it compatible only with specific models?

  The Medi-Trace 1310P is designed for use with automated external defibrillators (non-wearable) in general, though compatibility should be confirmed with the specific defibrillator model in use. Its integrated design supports defibrillation, ECG monitoring, and temporary pacing, making it versatile for emergency cardiac care.