# K150055: OneStep Pediatric CPR Multi-Function Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Detek, Inc.
- Decided: May 2, 2015 after 110 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K962603 (1997). 37 ancestors in all.
No later device cites it as a predicate yet.
1 of 38 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120907: Zoll R Series, Zoll Medical Corporation, World Wide Headquarters (2012) Summary page 4.
- K133441: Onestep CPR II Multi-Function Electrode, Bio-Detek, Inc. (2014) Summary page 4.

## Indications for use
Defibrillation Cardioversion Noninvasive Pacing ECG Monitoring CPR Feedback For use with ZOLL® Defibrillators, such as: R Series X Series Trained Personnel only, Including: Physicians Nurses Paramedics Emergency Medical Technicians Cardiovascular Laboratory Technicians The OneStep Pediatric CPR electrodes are indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).

Source page: https://510kreport.com/device/K150055
Methodology: https://510kreport.com/methodology