# K122758: Powerheart G5 Aed

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Science Corporation
- Decided: Feb 12, 2014 after 520 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: 8 generations back to K970741 (1997). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102496: Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed G3 Pro, Powerheart Aed G3 Plus, Cardiac Science Corporation (2011) Summary page 1.
- K082090: 9131 Defibrillation Electrodes, Cardiac Science Corporation (2008) Summary page 1.
- K022929: Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model 9200/9210, Cardiac Science, Inc. (2003) Summary page 1.

## Most influential descendants
- K143714: Powerheart G5 AED (2015), 0 descendants of its own

## Indications for use
The G5 Automated External Defibrillator (AED) is intended to be used by persons who have been trained in its operation. The user should be trained in basic life support or other physician-authorized emergency medical response. An AED is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing or not breathing normally. Post-resuscitation, if the patient is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and advise the operator to deliver a shock, or for an automatic AED, automatically deliver a shock if needed. When a patient is a child up to 8 years of age, or up to 25kg (55 Ibs), the AED should be used with the Pediatric Defibrillation Pads. The therapy should not be delayed to determine the patient's exact age or weight.

Source page: https://510kreport.com/device/K122758
Methodology: https://510kreport.com/methodology