Selectrode

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

510(k) Number

K894920 ↗

FDA Product Code

DRX

Device Class

Class II

Regulation

21 CFR Part 870.2360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Are Selectrode electrodes reusable or designed for single-use, and why does this matter for clinical settings?

  Selectrode electrodes are designed for single-use only, as explicitly stated in the manufacturer’s instructions. This is important because single-use electrodes reduce the risk of cross-contamination between patients, ensuring hygiene and safety in clinical settings like ECG monitoring. Reusing them could compromise sterility and introduce infection risks, which is why they are classified as disposable.

• What types of clinical environments or procedures are these electrodes intended for, and how does their design support that use?

  Selectrode electrodes are intended for cardiovascular settings, specifically for electrocardiographic (ECG) monitoring and diagnostic procedures. Their design facilitates accurate detection of the heart’s electrical activity by securely attaching leads to the patient’s skin, enabling reliable recordings for clinical assessment. The temporary skin contact ensures they are suitable for routine ECG use without prolonged adhesion.

• How should I store Selectrode electrodes to ensure they remain sterile and functional, according to the manufacturer’s guidelines?

  The manufacturer specifies that Selectrode electrodes must be stored according to their guidelines to maintain sterility and functionality. While the exact storage conditions (e.g., temperature, humidity, packaging) aren’t detailed here, typical best practices for single-use, sterile medical devices—such as keeping them in sealed, unopened packaging away from direct sunlight or extreme temperatures—should be followed. Always refer to the included instructions for precise storage instructions.

• What does the FDA’s classification of Selectrode as Class II mean for healthcare providers using this device?

  The FDA’s classification of Selectrode as Class II under regulation 870.2360 indicates it undergoes traditional 510(k) clearance, meaning its safety and effectiveness have been reviewed by the FDA through a premarket submission process. This classification doesn’t imply higher risk but ensures the device meets established performance standards for ECG electrodes. For providers, this means the device has undergone regulatory scrutiny for its intended use in ECG monitoring.