# K143714: Powerheart G5 AED

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Science Corporation
- Decided: May 4, 2015 after 126 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: 9 generations back to K970741 (1997). 26 ancestors in all.
No later device cites it as a predicate yet.
1 of 27 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122758: Powerheart G5 Aed, Cardiac Science Corporation (2014) Summary page 4.
- K120406: Zoll Fully Automatic Aed Plus, Zoll Medical Corporation, World Wide Headquarters (2012) Summary page 4.

## 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 1bs), 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. The optional CPR Device offers CPR performance feedback to aid a trained rescuer by providing compression rate and depth performance feedback through audio prompting. The CPR Device is indicated for use on cardiac arrest patients 8 years of age or older, or who weigh more than 25 kg (55 Ibs).

Source page: https://510kreport.com/device/K143714
Methodology: https://510kreport.com/methodology