Zoll SuperPadz Adult Multi-Function Electrodes, Model 8900-XXXX

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

510(k) Number

K984582 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Bio-Detek, Inc. →

• Are these electrodes suitable for use in both emergency and clinical settings, and if so, how are they maintained between uses?

  Yes, the Zoll SuperPadz Adult Multi-Function Electrodes (Model 8900-XXXX) are designed for use in prehospital, clinical, and emergency settings. Since they are reusable, proper cleaning and maintenance between uses are essential. The manufacturer provides guidelines for this process, ensuring the electrodes remain functional for repeated use in cardiac rhythm analysis and synchronized shock delivery during cardiac arrest or arrhythmias.

• What types of defibrillators are these electrodes compatible with, and are they sterile?

  The Zoll SuperPadz Adult Multi-Function Electrodes are specifically designed for use with automated external defibrillators (non-wearable). They are not sterile, which is explicitly stated in the product description. This means they must be cleaned and disinfected between uses, as they are intended for reusable applications.

• How do I know if these electrodes are appropriate for my facility’s needs, given their regulatory classification?

  These electrodes are classified as Class III medical devices under FDA regulations (870.5310) and were cleared via a traditional 510(k) pathway with a decision of *Substantially Equivalent* by the Cardiovascular (CV) Advisory Committee. They are registered under product code MKJ and are intended for cardiac rhythm analysis and synchronized shock delivery in cardiac arrest or arrhythmias. If your facility requires reusable, multi-function electrodes for non-wearable defibrillators, this product meets those criteria.

• Are there different sizes or models available for this electrode, and how do I determine the correct fit for a patient?

  The Zoll SuperPadz Adult Multi-Function Electrodes are supplied as reusable components under the Model 8900-XXXX designation, but the provided data does not specify multiple sizes or models beyond this general adult classification. Since they are designed for adult use, they should be appropriate for most adult patients requiring defibrillation. Always follow manufacturer instructions for proper placement and ensure the electrodes adhere securely to the patient’s chest for optimal performance.