Blue Sensor, Disposable ECG Electrodes for Anaesthesia

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

510(k) Number

K020382 ↗

FDA Product Code

DRX

Device Class

Class II

Regulation

21 CFR Part 870.2360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Blue Sensor Supatab Disposable ECG Electrodes

  Class II

  FDA 510(k) K983689 Active Cleared 15 Jan 1999

• Neuroline, Disposable Concentric Needle Electrodes

  Class II

  FDA 510(k) K973529 Active Cleared 20 Nov 1997

• Multi-Function Defibrillation Electrode

  Class III

  FDA 510(k) K002079 Active Cleared 22 Feb 2001

• Medicom, Tens Electrodes

  Class II

  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

• What is the intended use of Blue Sensor disposable ECG electrodes for anaesthesia?

  Blue Sensor disposable ECG electrodes for anaesthesia are designed for surface application to transmit body surface electrical signals to an external processor for ECG or vectorcardiogram generation, specifically intended for use during anesthesia by physicians or clinicians in clinical or operating room settings.

• Are Blue Sensor ECG electrodes reusable or single-use?

  Blue Sensor ECG electrodes are intended for single-patient use and are supplied as disposable devices, meaning they are designed for one-time use on a single patient and should not be reused due to infection control and signal integrity considerations.

• What regulatory clearance does the Blue Sensor ECG electrode have?

  The Blue Sensor disposable ECG electrode for anaesthesia received FDA 510(k) clearance under K020382 with a decision date of June 28, 2002, and is classified under product code DRX as substantially equivalent to a predicate device.