Zoll Stat*padz Adult Multi-Function Electrodes Model Number 8900-4003

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

510(k) Number

K981802 ↗

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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  Class III

  FDA 510(k) K033771 Active Cleared 27 Feb 2004

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  Class II

  FDA 510(k) K912714 Active Cleared 25 Jul 1991

• Zoll First Responder Padz Adult Defibrillation Electrodes

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  Class II

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  FDA 510(k) K920264 Active Cleared 2 Jun 1992

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See all devices from Bio-Detek, Inc. →

• Are these electrodes suitable for use on pediatric patients, or are they strictly for adults?

  These electrodes, the ZOLL StatPADZ Adult Multi-Function Electrodes (Model 8900-4003), are explicitly designed for adult patients only. The product name and description emphasize their use in adult cardiac arrest or defibrillation scenarios, so they are not intended for pediatric applications.

• How should I store these electrodes to ensure they remain functional?

  The manufacturer recommends following their storage guidelines to maintain functionality. While the data does not specify exact conditions (e.g., temperature or humidity), standard practice for single-use, non-sterile electrodes like these typically involves keeping them in a cool, dry place away from direct sunlight and extreme temperatures until use. Always refer to the included instructions for precise storage instructions.

• Can these electrodes be reused after a single use, or are they meant to be discarded immediately?

  These electrodes are single-use only and should be discarded after one use. The product description explicitly states they are supplied as disposable devices, which is standard for defibrillation electrodes to ensure safety, hygiene, and reliability during critical interventions.

• What types of procedures or settings are these electrodes intended for?

  The ZOLL StatPADZ Adult Multi-Function Electrodes are designed for use in both pre-hospital and in-hospital settings by trained personnel. They are intended for defibrillation, cardioversion, and synchronized pacing in adult patients experiencing cardiac arrest or requiring electrical interventions for abnormal heart rhythms.

• What regulatory pathway was followed for FDA clearance of these electrodes?

  These electrodes were cleared through the traditional 510(k) review pathway by the FDA’s Cardiovascular Advisory Committee. The clearance was granted in 1998 under the substantially equivalent (SESE) determination, confirming they meet the regulatory requirements for Class III defibrillation devices (21 CFR 870.5310).