# K133441: Onestep CPR II Multi-Function Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Detek, Inc.
- Decided: Oct 10, 2014 after 332 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: 9 generations back to K962603 (1997). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 29 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110742: Onestep Adult Multi-Function Electrode, ZOLL Medical Corporation (2011) Summary page 4.

## Most influential descendants
- K150055: OneStep Pediatric CPR Multi-Function Electrode (2015), 0 descendants of its own

## Indications for use
Defibrillation Cardioversion Noninvasive Pacing ECG Monitoring CPR Sensor For use on adult patients with ZOLL® R Series® defibrillator by trained personnel only, including: Physicians Nurses Paramedics Emergency Medical Technicians Cardiovascular Laboratory Technicians The OneStep CPR II Adult Electrodes are not 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/K133441
Methodology: https://510kreport.com/methodology