# K091943: Powerheart Aed G3, Model 9390E, Powerheart Aed G3 Automatic, Model 9390A

- Pathway: 510(k) (Special)
- Applicant: Cardiac Science Corporation
- Decided: Sep 10, 2009 after 72 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010214 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052161: Powerheart Aed G3 (Model 9390E), Powerheart Aed G3 Automatic (Model 9390A), Cardiac Science, Inc. (2005) Summary page 2.
- K010214: Firstsave Biphasic Model #9200 and 9210, Survivalink Corp. (2001) Summary page 2.

## Recalls of this device
- Feb 3, 2010 · Not classified · Z-1248-2010: A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
- Feb 3, 2010 · Not classified · Z-1247-2010: A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
- Feb 3, 2010 · Not classified · Z-1249-2010: A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
- Feb 3, 2010 · Not classified · Z-1244-2010: A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
- Feb 3, 2010 · Not classified · Z-1246-2010: A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
- Feb 3, 2010 · Not classified · Z-1243-2010: A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
- Feb 3, 2010 · Not classified · Z-1245-2010: A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.

## Indications for use
The Powerheart AED G3 and the Powerheart AED G3 Automatic devices are 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 charge 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.

Source page: https://510kreport.com/device/K091943
Methodology: https://510kreport.com/methodology