# K102496: Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed G3 Pro, Powerheart Aed G3 Plus

- Pathway: 510(k) (Special)
- Applicant: Cardiac Science Corporation
- Decided: Jun 9, 2011 after 282 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K970741 (1997). 17 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031987: Powerheart Aed G3, Model 9300, Cardiac Science (2003) Summary page 2.
- K040438: Powerheart Aed G3A, Cardiac Science, Inc. (2004) Summary page 2.
- K040637: Powerheart Aed G3 Pro, Cardiac Science, Inc. (2004) Summary page 2.
- K052161: Powerheart Aed G3 (Model 9390E), Powerheart Aed G3 Automatic (Model 9390A), Cardiac Science, Inc. (2005) Summary page 2.

## Most influential descendants
- K122758: Powerheart G5 Aed (2014), 1 descendant of its own
- K143714: Powerheart G5 AED (2015), 0 descendants of its own

## Recalls of this device
- Jan 14, 2016 · Class II · Z-0829-2016: Defibrillation electrodes may increase electrical impedance over time. If impedance becomes too high, the AED will fail the electrode self-test and it will not be Rescue Ready, the AED STATUS INDICATO
- Jan 13, 2012 · Not classified · Z-1057-2012: The affected Automated External Defibrillators (AEDs) contains a circuit board manufactured with a component that may fail unexpectedly due to a supplier manufacturing defect. If the component were to

## Indications for use
The Powerheart® AED G3 family of devices is intended to be used by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response. The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will change automatically and advise the operator to deliver therapy (G3) or automatically deliver the charge (G3 Automatic). When the patient is a child or infant up to 8 years of age, or up to 55 lbs (25kg), the device should be used with the Model 9730 Pediatric Attenuated Defibrillation Electrodes. The therapy should not be delayed to determine the patient's exact age or weight. Additional information exclusive to the Power/wart®AED G3 Pro, Model 9300P: At the discretion of emergency care personnel, the G3Pro with EGG display enabled can also be used with Model 5111 EGG Patient Cable to display the rhythm of a responsive or breathing patient, regardless of age. The G3Pro and EGG Patient Cable system provides a non-diagnostic display for attended patient monitoring. While connected the G3Pro EGG Patient Gable, the G3Pro evaluates the patient's EGG and disables its shock capability.

Source page: https://510kreport.com/device/K102496
Methodology: https://510kreport.com/methodology