Zoll First Responder Padz Adult Defibrillation Electrodes

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

510(k) Number

K990106 ↗

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

• RT40 Radio Translucent

  Class II

  FDA 510(k) K912714 Active Cleared 25 Jul 1991

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

  Class III

  FDA 510(k) K981802 Active Cleared 25 Nov 1998

• DE12 Rapid Trace at-Rest Diagnostic ECG Electrodes

  Class II

  FDA 510(k) K853038 Active Cleared 7 Jan 1986

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  Class II

  FDA 510(k) K920264 Active Cleared 2 Jun 1992

• OneStep Pediatric CPR Multi-Function Electrode

  Class III

  FDA 510(k) K150055 Active Cleared 2 May 2015

See all devices from Bio-Detek, Inc. →

• Are these electrodes reusable or designed for single-use only, and why does that matter in emergency settings?

  The Zoll First Responder Padz Adult Defibrillation Electrodes are intended for single-use only. This design ensures sterility and reliability in emergency resuscitation, as reuse could compromise the adhesive integrity, electrical performance, or introduce contamination risks. Single-use electrodes also eliminate the need for reprocessing, which is critical in time-sensitive scenarios like cardiac arrest where every second counts.

• How should these electrodes be stored before use, and what happens if they’re exposed to moisture or extreme temperatures?

  These electrodes must be stored in a dry, protected environment prior to use, as specified by the manufacturer. Exposure to moisture or extreme temperatures could degrade the adhesive properties, compromise sterility, or damage the conductive components. Proper storage ensures the electrodes remain functional and safe for use in emergency defibrillation scenarios.

• Are these electrodes compatible with all automated external defibrillators (AEDs), or only specific brands like Zoll?

  These electrodes are specifically designed for compatibility with Zoll defibrillators only. While they are intended for use with automated external defibrillators (non-wearable), their electrical and adhesive properties are optimized for Zoll’s systems. Using them with non-Zoll devices may result in improper defibrillation performance or safety risks.

• What does the FDA 510(k) clearance mean for healthcare providers or facilities considering these electrodes?

  The FDA 510(k) clearance indicates that the Zoll First Responder Padz Adult Defibrillation Electrodes have been determined to be substantially equivalent to a legally marketed predicate device (a previously approved defibrillation electrode) and meet regulatory standards for safety and effectiveness. This clearance does not imply clinical superiority but confirms the device adheres to FDA requirements for Class III medical devices, ensuring they are suitable for emergency resuscitation use as described.