Medi-Trace 1610C Combination Defibrillation, Monitoring, and Pacing Electrode

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

510(k) Number

K983287 ↗

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 clinical environments is the Medi-Trace 1610C intended for use in, and why is this important?

  The Medi-Trace 1610C is designed for single-use in critical settings like emergency rooms, pre-hospital environments (e.g., ambulances), and cardiac care units. This is important because these environments require reliable, immediate cardiac interventions—such as defibrillation, real-time ECG monitoring, and temporary pacing—where delays or equipment failures could have life-threatening consequences. Its versatility in combining these functions into one electrode streamlines resuscitation efforts in high-stress scenarios.

• How should the Medi-Trace 1610C be stored to maintain its sterility and functionality?

  The Medi-Trace 1610C must be stored in its original, sealed packaging until first use to preserve sterility. This is explicitly stated in the device description, as it ensures no contamination occurs before application. Proper storage is critical because the electrode is intended for single-use in sterile clinical procedures, and compromised sterility could introduce infection risks during life-saving interventions.

• Is the Medi-Trace 1610C compatible with all defibrillators and monitoring systems, or are there specific requirements?

  While the Medi-Trace 1610C is designed for use with defibrillators and monitoring systems, compatibility must be verified before application. The device description emphasizes this requirement, as not all systems may support its combined functions (defibrillation, pacing, and ECG monitoring). Clinicians should confirm compatibility with their specific equipment to ensure accurate performance and avoid malfunctions during critical interventions.

• Why is the Medi-Trace 1610C classified as a Class III medical device, and what does this mean for its use?

  The Medi-Trace 1610C is classified as a Class III device due to its role in life-saving cardiac interventions, such as defibrillation and pacing, which carry significant risks if misused or malfunctioning. This classification reflects the FDA’s stringent regulatory oversight, ensuring the device meets rigorous safety and effectiveness standards. For users, this means the device undergoes thorough validation, and its use must adhere strictly to manufacturer guidelines to maintain patient safety.

• Can the Medi-Trace 1610C be reused, and if not, what are the implications for clinical workflows?

  No, the Medi-Trace 1610C is explicitly designed for single-use only, as stated in the device description. This design choice eliminates risks associated with reuse, such as contamination or electrode degradation, which could compromise its performance in critical situations. Clinically, this means each patient requires a new electrode, which may impact inventory management and workflow planning in high-volume settings like emergency departments or pre-hospital care.