# K040438: Powerheart Aed G3A

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Science, Inc.
- Decided: Jul 1, 2004 after 133 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 25 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K970741 (1997). 12 ancestors in all.
6 later devices descend from it; 4 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)
- K031987: Powerheart Aed G3, Model 9300, Cardiac Science (2003) Summary page 1.
- 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) Summary page 1.
- K982264: Firstsave Biphasic Models 9200 and 9210, Survivalink Corp. (1999) Summary page 2.
- K011144: Lifepak 600 Automated External Defibrillator, Medtronic Physio-Control Corp. (2001)

## 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
- K141231: ZP9141, ZP9146Y, ZP9146W Non-Rechargeable Battery (2014), 0 descendants of its own
- K120350: Extended Life Battery (2012), 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-0921-2009: Potential for AED to not deliver defibrillation therapy.
- Jan 27, 2006 · Not classified · Z-0623-06: Some Powerheart AED Model 9300A may contain a suspect electronic component and there is a remote likelihood that the function of this device may be interrupted during the charge.
- Nov 12, 2004 · Not classified · Z-0399-05: 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

## Indications for use
The Powerheart® AED G3A 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 lbs (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/K040438
Methodology: https://510kreport.com/methodology