# K031987: Powerheart Aed G3, Model 9300

- Pathway: 510(k) (Special)
- Applicant: Cardiac Science
- Decided: Jul 30, 2003 after 33 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 33 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K970741 (1997). 10 ancestors in all.
8 later devices descend from it; 6 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022929: Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model 9200/9210, Cardiac Science, Inc. (2003) Summary page 1.
- K011901: Firstsave Star Biphasic, Model 9210/9200, Survivalink Corp. (2002)
- K982264: Firstsave Biphasic Models 9200 and 9210, Survivalink Corp. (1999) Summary page 2.

## Most influential descendants
- K040438: Powerheart Aed G3A (2004), 6 descendants of its own
- K040637: Powerheart Aed G3 Pro (2004), 3 descendants of its own
- 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

## Recalls of this device
- 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
- 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.
- Dec 18, 2009 · Not classified · Z-1810-2010: The K302 relay switch of the G3 series AED product line may experience an early failure. If the K302 contacts are open at the time of rescue, there is a possible delay in therapy or failure to deliver
- 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 12, 2009 · Not classified · Z-1424-2010: Certain models of Powerheart G3 AEDs may not have received adequate electrical safety testing prior to being shipped from the factory. Affected models are: Powerheart 9300A, 9300C, 9300D, 9300E, 9300P
- Oct 13, 2008 · Not classified · Z-0916-2009: Potential for AED to not deliver defibrillation therapy.
- Oct 13, 2008 · Not classified · Z-0920-2009: Potential for AED to not deliver defibrillation therapy.
- Oct 13, 2008 · Not classified · Z-0919-2009: Potential for AED to not deliver defibrillation therapy.
- Oct 13, 2008 · Not classified · Z-0918-2009: Potential for AED to not deliver defibrillation therapy.
- Oct 13, 2008 · Not classified · Z-0917-2009: Potential for AED to not deliver defibrillation therapy.
- Nov 12, 2004 · Not classified · Z-0398-05: AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not functionn properly and may interfere with the AED
- May 4, 2004 · Not classified · Z-0991-04: Some of the recalled defibrillator batteries contain an incorrect fuse which could open resulting in a defibrillator which will not work.
- May 4, 2004 · Not classified · Z-0990-04: Some of the recalled defibrillator batteries contain an incorrect fuse which could open resulting in a defibrillator which will not work.

## Indications for use
The Powerheart@ AED G3 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 the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and advise the operator to deliver therapy. When a patient is a child or infant up to 8 years of age, or up to 55 Ibs (25kg), the Powerheart AED G3 should be used with the Model 9730 Pediatric Attentuated Defibrillation Electrodes. The therapy should not be delayed to determine the patient's exact age or weight.

Source page: https://510kreport.com/device/K031987
Methodology: https://510kreport.com/methodology