# K022732: Infant/Child Reduced Energy Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Physio-Control Corp.
- Decided: Dec 13, 2002 after 119 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 4 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003819 (2001). 1 ancestor in all.
75 later devices descend from it; 3 cite it directly.
1 of 77 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003819: Heartstream Attenuated Defibrillation Pads, Model M3870A, Agilent Technologies, Inc. (2001)

## Cited in the summary but kept off the family tree
- K979301: Medtronic Physio-Control Pediatric QUIK-COMBO electrodes. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Most influential descendants
- K033474: Zoll Aed Plus (2004), 72 descendants of its own
- K042007: Zoll E Series Defibrillator (2005), 64 descendants of its own
- K090989: Zoll R Series with Nibp and ETCO2 Options, Zoll R Series (2009), 27 descendants of its own
- K151644: Masimo Root Vital Signs Monitoring System and Accessories (2016), 24 descendants of its own
- K041892: Zoll Aed Pro External Defibrillator (2005), 23 descendants of its own

## Recalls of this device
- Apr 24, 2020 · Class II · Z-2360-2020: Packaging of infant child reduced energy electrodes was not properly sealed.
- Apr 24, 2020 · Class II · Z-2359-2020: Packaging of infant child reduced energy electrodes was not properly sealed.
- Oct 27, 2017 · Class I · Z-0186-2018: The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.
- Oct 27, 2017 · Class I · Z-0187-2018: The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.

## Indications for use
Use the Infant/Child defibrillation electrodes on an infant or child up to 8 years old or up to 25kg (551bs). Do not delay therapy to determine child’s exact age or weight. These electrodes are to be used only with LIFEPAK CR PLUS defibrillators and biphasic LIFEPAK 500 AEDs configured with a pink cable connector. The LIFEPAK CR PLUS and LIFEPAK 500 biphasic defibrillators are indicated for use on patients in cardiopulmonary arrest. The patient must be unconscious, not breathing normally, and showing no signs of circulation (for example, no pulse, and/or no coughing, no movement) before the device is used to analyze the patient’s ECG rhythm. The LIFEPAK CR PLUS and LIFEPAK 500 biphasic defibrillators 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.

Source page: https://510kreport.com/device/K022732
Methodology: https://510kreport.com/methodology