OneStep Pediatric CPR Multi-Function Electrode

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

510(k) Number

K150055 ↗

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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• What is the OneStep Pediatric CPR Multi-Function Electrode designed to measure during CPR, and how does it differ from standard electrodes?

  The OneStep Pediatric CPR Multi-Function Electrode integrates ECG monitoring, defibrillation, pacing, and cardioversion into a single device for pediatric patients under 55 pounds. Unlike standard electrodes, it includes dual-sensor technology with accelerometers on both pads to measure CPR depth and compressibility, compensating for variations in compressible surfaces like mattresses or bedding. This allows real-time feedback on compression quality, which is critical for effective resuscitation.

• Is this electrode reusable, and what storage guidelines should be followed?

  The OneStep Pediatric CPR Multi-Function Electrode is intended for single-use only, meaning it should not be reused after one application. Since it is non-sterile, it must be handled according to standard single-use medical device protocols—store in a clean, dry environment away from direct sunlight or extreme temperatures. Follow manufacturer instructions for expiration dates and disposal to ensure safety and compliance.

• Which defibrillator models is this electrode compatible with, and does it require additional accessories?

  This electrode is exclusively designed for use with ZOLL’s R Series and X Series defibrillators. It eliminates the need for separate leads or cables, as it combines ECG monitoring, defibrillation, pacing, and cardioversion into one integrated system. No additional accessories are required beyond the electrode pads themselves.

• How do I know if this electrode is appropriate for my pediatric patient, and what size range does it cover?

  The OneStep Pediatric CPR Multi-Function Electrode is specifically designed for pediatric patients under 55 pounds. While the device itself does not have interchangeable sizes, its universal pediatric sizing ensures proper fit and functionality for this weight range. Always verify patient weight and clinical context before use, as oversized or undersized electrodes could compromise performance.

• What regulatory pathway was followed for FDA clearance, and what does that mean for clinical trust?

  The OneStep Pediatric CPR Multi-Function Electrode received FDA 510(k) clearance (K150055) under the Traditional 510(k) Review pathway, with a decision described as *Substantially Equivalent* to predicate devices. This means the FDA reviewed it against existing, legally marketed electrodes and determined it meets safety and effectiveness standards for its intended use. The clearance was issued by the Cardiovascular (CV) Advisory Committee, reinforcing its clinical validation for pediatric defibrillation and monitoring applications.