Pedi-Padz Radiolucent Multi-Function Pediatric Electrodes, Model 8900-1005

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

510(k) Number

K040256 ↗

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

  The Pedi-Padz Radiolucent Multi-Function Pediatric Electrodes (Model 8900-1005) are explicitly designed for single-use only. This is critical in clinical settings because single-use electrodes reduce the risk of cross-contamination between patients, ensuring sterility and safety—especially in high-risk areas like emergency rooms, intensive care units, or operating rooms where pediatric patients may have compromised immune systems or fragile skin.

• How do I ensure these electrodes remain effective and sterile during storage, given their sensitivity to environmental conditions?

  To maintain functionality and sterility, these electrodes must be stored protected from extreme temperatures and moisture. The manufacturer’s instructions emphasize this, as exposure to heat, cold, or humidity could compromise the adhesive properties, electrical conduction, or sterility—all of which are essential for reliable use in pediatric cardiovascular monitoring or defibrillation.

• What sizes or models are available for pediatric patients, and how do I determine the correct fit for a specific child?

  The provided data only specifies Model 8900-1005, which is designed for pediatric use but does not list additional sizes. Since pediatric patients vary significantly in size, the electrodes are likely engineered with adjustable or universal sizing to accommodate a range of chest sizes. Clinicians should refer to the manufacturer’s sizing guidelines (available in the product documentation) to ensure proper placement for accurate monitoring or defibrillation.

• Why is radiolucency important for these electrodes, and how does it impact their use in imaging procedures?

  The electrodes are radiolucent, meaning they allow X-rays to pass through without blocking the view. This is crucial in pediatric cardiovascular applications where real-time imaging (e.g., fluoroscopy or X-ray) may be required alongside electrocardiogram monitoring or defibrillation. Radiolucency ensures that the imaging equipment can still capture clear visuals of the patient’s anatomy without interference from the electrodes.

• What regulatory pathway was followed for FDA clearance, and does this affect how I should handle or implement these electrodes in my facility?

  The Pedi-Padz electrodes received FDA 510(k) clearance through a traditional review process, classified under Class III (device code MKJ) for cardiovascular applications. While this confirms their compliance with U.S. safety and performance standards, it does not alter clinical handling—facilities must still follow standard infection control protocols (e.g., single-use disposal, proper storage) as outlined by the manufacturer and regulatory guidelines to ensure safe and effective use.