Marquette Defib Electrode

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

510(k) Number

K941262 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Alarm Display Unit/Pager-Lan System (Adu)

  Class II

  FDA 510(k) K962827 Active Cleared 24 Feb 1997

• Marquette 1200 Defibrillator

  Class III

  FDA 510(k) K882067 Active Cleared 17 Nov 1988

• Pulse Oximetry Module

  Class II

  FDA 510(k) K901071 Active Cleared 19 Jun 1990

• Smart Anesthesia Multi-Gas (Sam) Module

  Class II

  FDA 510(k) K943977 Active Cleared 23 Mar 1995

• Cardiosoft/Cardiosys

  Not classified

  FDA 510(k) K951130 Active Cleared 4 Apr 1996

• Silver Mactrode

  Class II

  FDA 510(k) K902176 Active Cleared 4 Sep 1990

See all devices from Marquette Electronics, Inc. →

• Are these electrodes reusable or single-use, and why does that matter in an emergency setting?

  The Marquette Defib Electrode is designed for single-use only and must not be reused. This is critical in emergency settings because repeated use could compromise electrode integrity, reduce effectiveness, and introduce contamination risks, potentially delaying defibrillation or compromising patient safety. Single-use electrodes ensure reliability and sterility in life-threatening situations.

• How should I store these electrodes to maintain their performance and shelf life?

  The electrodes must be stored in a clean, dry environment as specified by the manufacturer. Proper storage prevents moisture damage, contamination, or degradation of adhesive properties, which could impair adhesion to the patient’s chest or reduce signal quality during defibrillation. Avoid exposure to extreme temperatures or direct sunlight.

• Can these electrodes be used with any automated external defibrillator, or are they specific to a brand?

  The Marquette Defib Electrode is intended for use with automated external defibrillators, but its compatibility is specifically designed for Marquette Electronics’ systems. While the exact model compatibility isn’t detailed here, it’s critical to confirm with the manufacturer or device manual to ensure proper function, as mismatched electrodes could lead to ineffective defibrillation or device malfunctions.

• What safety considerations should I keep in mind when using these electrodes, particularly regarding MRI environments?

  The Marquette Defib Electrode is not MRI-safe, meaning it should never be used in or near an MRI scanner. Metallic components in the electrode could react to the magnetic field, causing injury to the patient or damage to the MRI equipment. Always ensure the patient is removed from the MRI environment before applying these electrodes.

• What regulatory pathway was followed for this device, and what does that mean for its safety and reliability?

  The Marquette Defib Electrode received FDA 510(k) clearance (K941262), which means it was determined to be substantially equivalent to a legally marketed predicate device. This pathway ensures the device meets FDA standards for safety and effectiveness as a Class III cardiovascular device (regulated under 21 CFR 870.5310). The clearance reflects rigorous review by the FDA’s Cardiovascular (CV) advisory committee, validating its design for defibrillation in emergency cardiac arrest scenarios.