OneStep CPR II Multi-Function Electrode

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

510(k) Number

K133441 ↗

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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See all devices from Bio-Detek, Inc. →

• What is the primary purpose of the OneStep CPR II Multi-Function Electrode, and how does it differ from standard defibrillation electrodes?

  The OneStep CPR II Multi-Function Electrode is specifically designed for use with automated external defibrillators (non-wearable) to deliver synchronized electrical shocks during cardiac arrest. Unlike standard electrodes, it incorporates additional CPR feedback functionality, allowing it to provide real-time guidance during chest compressions while also enabling defibrillation. This dual-purpose feature helps improve resuscitation efforts by combining defibrillation with performance monitoring.

• Is this electrode single-use or reusable, and what does that mean for clinical workflows?

  The OneStep CPR II Multi-Function Electrode is intended for single-use only, meaning it should not be reused on multiple patients. This design choice aligns with standard medical device protocols for defibrillation electrodes to ensure patient safety, sterility, and compliance with infection control practices. Clinicians should discard it after a single use and replace it with a new electrode for subsequent resuscitations.

• How should the OneStep CPR II Multi-Function Electrode be stored, and are there any special handling instructions?

  The electrode follows standard medical device storage protocols for defibrillation electrodes, though it is explicitly noted as non-sterile. It should be stored in a clean, dry environment away from direct sunlight or extreme temperatures, following the manufacturer’s guidelines to maintain functionality. Unlike some devices, there are no MRI safety considerations specified, so magnetic resonance environments are not a concern for storage or handling.

• What regulatory pathway was followed for FDA clearance, and how does this affect its use in clinical settings?

  The OneStep CPR II Multi-Function Electrode received FDA 510(k) clearance (K133441) under the Traditional 510(k) Review pathway, demonstrating it is substantially equivalent to a predicate device. This clearance confirms it meets FDA standards for safety and effectiveness as a Class III device (870.5310), which is the highest risk classification for defibrillation electrodes. Clinicians can rely on this approval when integrating it into emergency protocols for automated external defibrillation.