Zoll Stat*padz Mwp Multi-Function Electrodes

• • Terminated Z-2334-2008 FDA Unclassified (pre-2012) ·initiated 16 Jun 2008 ·on shared 510(k) K051076

  Multi-function electrode programmed as a Pediatric instead of Adult

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K051076 ↗

FDA product code

MKJ

Device class

Class III

Regulation

21 CFR Part 870.5310

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

• 8900-0400

  Class I

  CE/MDR

• R Series

  Class IIb

  CE/MDD

• Onestep Cpr Adult Electrodes

  Class I

  CE/MDR

• 731 Ventilator

  Class IIb

  CE/MDD

• Zenix 1116-111075-21-Usa-0

  Class III

  GUDID on market

• Radiotransparent Defibrillation Electrode 8900-004041-01

  Class III

  GUDID on market

See all devices from Zoll Medical Corporation →

• Are these electrodes reusable or single-use, and why does that matter in an emergency setting?

  The Zoll StatPadz MWP Multi-Function Electrodes are designed for single-use only, ensuring sterility and hygiene for each patient encounter. This is critical in emergency settings like cardiac arrest or cardioversion, where contamination risks could compromise patient safety or treatment efficacy. Single-use electrodes also eliminate cross-infection risks between patients, which is especially important in high-stress environments where time and sterility are paramount.

• What types of devices are these electrodes compatible with, and how do I confirm compatibility before use?

  These electrodes are explicitly designed for compatibility with automated external defibrillators (AEDs) and defibrillator-monitor devices, including those from Zoll and other manufacturers. The packaging indicates they are pre-tested for clinical readiness with these systems, but users should always verify compatibility with their specific device model by checking the manufacturer’s documentation or labeling. This ensures proper function for defibrillation, cardioversion, noninvasive pacing, and ECG monitoring.

• How are the electrodes packaged, and what should I check before opening them for use?

  Each pair of StatPadz MWP electrodes is packaged individually in sterile, single-use packaging to maintain sterility until use. Before opening, verify the packaging is intact (no tears or damage) and that the expiration date hasn’t passed. The adhesive should also appear dry and undamaged. If the packaging is compromised or the electrodes appear wet/dirty, discard them and use a fresh pair to ensure proper function and patient safety.

• Can these electrodes be used for noninvasive pacing, and if so, how does that differ from their defibrillation use?

  Yes, these electrodes support noninvasive pacing in addition to defibrillation and cardioversion. Noninvasive pacing uses low-energy electrical impulses to stimulate the heart rhythm, typically for temporary rate control or rhythm regulation during emergencies like bradycardia. Unlike defibrillation (which delivers high-energy shocks to reset chaotic rhythms), noninvasive pacing is a lower-energy, continuous or intermittent stimulation to maintain a stable heartbeat—useful when defibrillation isn’t indicated but pacing support is needed.

• What storage conditions are recommended to keep these electrodes functional and sterile until use?

  The electrodes should be stored in a cool, dry place (typically 15°C–30°C / 59°F–86°F) away from direct sunlight or extreme humidity. Avoid storing them in areas prone to temperature fluctuations (e.g., near heating vents or in direct sunlight), as this could degrade the adhesive or compromise sterility. Unopened, sterile packaging should be kept sealed until use to maintain integrity. Always check the expiration date before use, as prolonged storage may affect performance.