# K052161: Powerheart Aed G3 (Model 9390E), Powerheart Aed G3 Automatic (Model 9390A)

- Pathway: 510(k) (Special)
- Applicant: Cardiac Science, Inc.
- Decided: Oct 21, 2005 after 73 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Powerheart® AED G3: named in the summary without a submission number
- (no number) Powerheart® AED G3 Automatic: named in the summary without a submission number

## Most influential descendants
- K102496: Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed G3 Pro, Powerheart Aed G3 Plus (2011), 2 descendants of its own
- K122758: Powerheart G5 Aed (2014), 1 descendant of its own
- K143714: Powerheart G5 AED (2015), 0 descendants of its own
- K091943: Powerheart Aed G3, Model 9390E, Powerheart Aed G3 Automatic, Model 9390A (2009), 0 descendants of its own

## Recalls of this device
- Jun 30, 2011 · Not classified · Z-3265-2011: Cardiac Science Corporation (CSC) has identified two errors, 0x48 and 0x99, that have repeatedly occurred during a device self-test in the G3 installed base over the last 6 years. These self test erro
- 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.
- Nov 13, 2009 · Not classified · Z-0765-2010: Potential for devices not to deliver therapy
- Nov 13, 2009 · Not classified · Z-0778-2010: Potential for devices not to deliver therapy
- Nov 13, 2009 · Not classified · Z-0766-2010: Potential for devices not to deliver therapy
- Nov 13, 2009 · Not classified · Z-0768-2010: Potential for devices not to deliver therapy
- Nov 13, 2009 · Not classified · Z-0769-2010: Potential for devices not to deliver therapy
- Nov 13, 2009 · Not classified · Z-0771-2010: Potential for devices not to deliver therapy
- Nov 13, 2009 · Not classified · Z-0775-2010: Potential for devices not to deliver therapy
- Nov 13, 2009 · Not classified · Z-0776-2010: Potential for devices not to deliver therapy
- Nov 13, 2009 · Not classified · Z-0777-2010: Potential for devices not to deliver therapy
- Nov 13, 2009 · Not classified · Z-0767-2010: Potential for devices not to deliver therapy
- Nov 13, 2009 · Not classified · Z-0770-2010: Potential for devices not to deliver therapy
- Nov 13, 2009 · Not classified · Z-0772-2010: Potential for devices not to deliver therapy
- Nov 13, 2009 · Not classified · Z-0773-2010: Potential for devices not to deliver therapy
- Nov 13, 2009 · Not classified · Z-0774-2010: Potential for devices not to deliver therapy
- Oct 13, 2008 · Not classified · Z-0922-2009: Potential for AED to not deliver defibrillation 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 the 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 a 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/K052161
Methodology: https://510kreport.com/methodology