Blue Sensor Supatab Disposable ECG Electrodes

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

510(k) Number

K983689 ↗

FDA Product Code

DRX

Device Class

Class II

Regulation

21 CFR Part 870.2360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Neuroline, Disposable Concentric Needle Electrodes

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  FDA 510(k) K973529 Active Cleared 20 Nov 1997

• Multi-Function Defibrillation Electrode

  Class III

  FDA 510(k) K002079 Active Cleared 22 Feb 2001

• Blue Sensor, Disposable ECG Electrodes for Anaesthesia

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  FDA 510(k) K020382 Active Cleared 28 Jun 2002

• Medicom, Tens Electrodes

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  FDA 510(k) K965194 Active Cleared 6 Mar 1997

• Diagnostic Electromyography Needle Electrode, Disposable Hypodermic Needle

  Class II

  FDA 510(k) K001869 Active Cleared 18 Sep 2000

• Neuroline, Subdermal Needle Electrodes

  Class II

  FDA 510(k) K020907 Active Cleared 14 Jun 2002

• Are these electrodes reusable or meant for single-patient use only, and how does that affect their clinical application?

  The Blue Sensor Supatab Disposable ECG Electrodes are explicitly designed for single-patient use only, as stated in the description. This ensures sterility and hygiene in clinical settings, reducing the risk of cross-contamination between patients. Their single-use nature also simplifies inventory management and disposal, aligning with standard ECG monitoring protocols where electrodes are discarded after one use.

• How are these electrodes supplied, and what does the sterile packaging ensure for the clinician?

  The electrodes are supplied sterile in packaging tailored for clinical use, as noted in the description. This ensures they are free from pathogens before application, minimizing infection risks during ECG procedures. Clinicians can rely on the sterility to maintain a safe environment when attaching them to patients for resting ECG or vectorcardiogram applications.

• What types of ECG readings can these electrodes support, and how do they interface with external devices?

  These electrodes are designed to capture electrical signals from the body surface for generating electrocardiograms (ECGs) or vectorcardiograms, as described. They transmit these signals to an external processor, which processes the data to produce the diagnostic readings. This makes them compatible with standard ECG machines used for resting ECG applications.

• What regulatory pathway was followed for FDA clearance, and what does that mean for their use in the U.S.?

  The Blue Sensor Supatab electrodes received a Traditional 510(k) clearance under the FDA’s Cardiovascular advisory committee, with a product code of DRX. This means the device was determined to be substantially equivalent to a legally marketed predicate device, allowing it to enter the U.S. market with FDA authorization. Clinicians and buyers can trust this clearance reflects compliance with FDA standards for ECG electrodes.