# K110742: Onestep Adult Multi-Function Electrode

- Pathway: 510(k) (Special)
- Applicant: ZOLL Medical Corporation
- Decided: Apr 13, 2011 after 27 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K962603 (1997). 26 ancestors in all.
9 later devices descend from it; 3 cite it directly.
1 of 36 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060559: Zoll R Series Defibrillator, ZOLL Medical Corporation (2006) Summary page 1.
- K051076: Zoll Stat*Padz MWP Multi-Function Electrodes, ZOLL Medical Corporation (2005) Summary page 1.

## Most influential descendants
- K120907: Zoll R Series (2012), 6 descendants of its own
- K133269: Zoll X Series (2014), 4 descendants of its own
- K141774: Zoll X Series (2014), 2 descendants of its own
- K202375: ZOLL Propaq M (2021), 1 descendant of its own
- K133441: Onestep CPR II Multi-Function Electrode (2014), 1 descendant of its own

## Recalls of this device
- Aug 4, 2017 · Class II · Z-0977-2018: A portion of one lot of ZOLL OneStep Complete Electrodes for adults will cause the defibrillator to deliver pediatric energy levels instead of adult energy levels when used with the ZOLL R Series Defi

## Indications for use
Defibrillation Cardioversion Noninvasive Pacing ECG Monitoring CPR Sensor, (Optional) For use with ZOLL® Defibrillators: R Series M Series By Trained Personnel only, Including: Physicians Nurses Paramedics Emergency Medical Technicians Cardiovascular Laboratory Technicians The OneStep Adult Electrodes are not indicated for use on a patient less than 8 years of age or weighs less than 55 Lbs. (25Kg).

Source page: https://510kreport.com/device/K110742
Methodology: https://510kreport.com/methodology