# K072430: Zoll Pedipadz Reduced Energy Electrode

- Pathway: 510(k) (Traditional)
- Applicant: ZOLL Medical Corporation
- Decided: Nov 6, 2007 after 69 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: 5 generations back to K970741 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915159: Pediatric Multi-Function Electrodes, Zmi Corp. (1992) Summary page 1.
- K022929: Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model 9200/9210, Cardiac Science, Inc. (2003) Summary page 1.

## Recalls of this device
- Dec 30, 2011 · Not classified · Z-1011-2012: Lack of an adequate silicone seal around the periphery of the attenuator enclosure may allow fluid to enter.

## Indications for use
The ZOLL pediopadzTM Reduced Energy Electrode is intended for defibrillation, ECG monitoring and noninvasive pacing of pediatric patients less than 8 year of age or weighing less than 55 lbs (25 kg). The ZOLL pediopadzT M Reduced Energy Electrode is intended for use only with ZOLL M Series and ZOLL E Series Biphasic AED Defibrillator products. The ZOLL M Series AED and ZOLL E Series AED Defibrillator products are intended to be used by personnel who have been trained on the device operation and in basic life support or other physician authorized emergency medical response system. The ZOLL M Series AED and ZOLL E Series AED Defibrillator products are indicated for use on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness Absence of breathing Absence of pulse.

Source page: https://510kreport.com/device/K072430
Methodology: https://510kreport.com/methodology