800 ECG Electrode

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

510(k) Number

K790507 ↗

FDA Product Code

DRX

Device Class

Class II

Regulation

21 CFR Part 870.2360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Daiscope & Accessories

  Class II

  FDA 510(k) K790506 Active Cleared 9 Apr 1979

• What clinical settings is the 800 ECG Electrode intended for use in, and why is this important for my facility?

  The 800 ECG Electrode is designed for use in clinical settings like hospitals and cardiac care units, as noted in its description. This is important because it ensures compatibility with environments where continuous or periodic ECG monitoring is critical, such as emergency rooms, intensive care units, or cardiac rehabilitation centers. Its single-use, sterile nature also aligns with infection control protocols in these high-risk areas.

• Is the 800 ECG Electrode reusable, and if not, what does this mean for my supply chain management?

  No, the 800 ECG Electrode is explicitly labeled as a single-use device. This means each electrode is intended for one patient encounter only, reducing cross-contamination risks. For supply chain management, this implies you’ll need to plan for higher frequency restocking of electrodes, but it simplifies inventory tracking since there’s no need for cleaning or reprocessing. Sterility is maintained for single-use, so no additional sterilization steps are required.

• What does the FDA 510(k) clearance (K790507) with a traditional review pathway mean for the reliability of this electrode?

  The FDA 510(k) clearance (K790507) indicates that the 800 ECG Electrode was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee and deemed substantially equivalent to a legally marketed device already on the market. The traditional review pathway suggests a thorough evaluation of its safety and performance for ECG monitoring. While clearance was granted in 1979, the device remains classified under product code DRX, which covers electrocardiographic leads and electrodes, ensuring it meets regulatory standards for accuracy in detecting heart electrical activity.

• How should I store the 800 ECG Electrode to maintain its sterility and performance?

  While the provided data doesn’t specify exact storage conditions, the electrode is sterile and single-use, so it should be stored in a dry, sealed packaging away from direct sunlight, extreme temperatures, or moisture. Check the packaging for any manufacturer-recommended storage instructions (e.g., refrigeration if applicable), as improper storage could compromise adhesion or sterility. Always follow the expiration date on the packaging to ensure optimal performance.

• Are there different sizes or models of the 800 ECG Electrode, and if so, how do I determine which one to use for a patient?

  The provided data does not mention specific sizes or models of the 800 ECG Electrode beyond its general description as a disposable adhesive electrode. Typically, ECG electrodes come in standard sizes (e.g., pediatric, adult, or large adult) to accommodate different patient body types. You’ll need to refer to the manufacturer’s instructions or packaging for size guidance, as electrode fit affects signal quality. If your facility uses multiple sizes, ensure compatibility with your ECG monitoring equipment.