# K040637: Powerheart Aed G3 Pro

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Science, Inc.
- Decided: Aug 6, 2004 after 149 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 8 (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). 13 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 17 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.
- K014157: HEARTSTREAMFR2 Aed with M3848A and M3849A, Models M3860A, M3861, M3840A, M3841A, Philips Medical Systems (2002)
- K013425: Heartstream/Heartstart FR2 Aed Ecg Cable, Models M3860A, M3861A, M3840A, M3841A, Philips Medical Systems (2002) Summary page 2.

## 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

## 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.
- Nov 12, 2004 · Not classified · Z-0400-05: 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 G3 Pro, model 9300P, 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 Pro 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. At the discretion of emergency care personnel, the G3Pro with ECG display enabled can also be used with the Model 5111 ECG Patient Cable to display the rhythm of a responsive or breathing patient, regardless of age. The G3Pro and ECG Patient Cable system provides a non-diagnostic display for attended patient monitoring. While connected the G3Pro ECG Patient Cable, the G3Pro evaluates the patient's ECG and disables its shock capability.

Source page: https://510kreport.com/device/K040637
Methodology: https://510kreport.com/methodology