# K110978: Onestep Pediatric Mfe's

- Pathway: 510(k) (Abbreviated)
- Applicant: ZOLL Medical Corporation
- Decided: May 13, 2011 after 36 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: 3 generations back to K003819 (2001). 4 ancestors in all.
7 later devices descend from it; 1 cites it directly.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931787: Zoll PD 5300, Zoll Medical Corp (1993) Summary page 1.
- K033474: Zoll Aed Plus, Zoll Medical Corp (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K060559: Zoll R Series Defibrillator, ZOLL Medical Corporation (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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
- K233354: WVSM Pro (Series) (500-0030-XX) (2024), 0 descendants of its own

## Indications for use
Intended Use: Defibrillation Cardioversion Noninvasive Pacing ECG Monitoring For use with ZOLL Defibrillators: ZOLL Defibrillators, such as; R Series M Series E Series By Trained Personnel only, Including: Physicians Nurses Paramedics Emergency Medical Technicians Cardiovascular Laboratory Technicians The OneStep Pediatric Electrodes are 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/K110978
Methodology: https://510kreport.com/methodology