510(k) · Cleared
Recalled · Class II · 2016Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed G3 Pro, Powerheart Aed G3 Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiac Science Corporation · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Jun 9, 2011 as substantially equivalent to K031987 (Cardiac Science, 2003) and 3 other predicates after a 282-day review. Its family tree reaches back 7 generations to 1997. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 9, 2011
- Review
- 282 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 7 generations to K970741 (1997). 17 ancestors in all, the oldest K955628 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK970741 Powerheart AecdCardiac Science, Inc. · 1997 · Recalled
- 6 generations backK982710 Aecd Arrhythmia Detection SoftwareCardiac Science, Inc. · 1998 · Recalled
- 5 generations backK993533 Powerheart AecdCardiac Science, Inc. · 2000 · Recalled
- 4 generations backK011901 Firstsave Star Biphasic, Model 9210/9200Survivalink Corp. · 2002 · Recalled
- 3 generations backK022929 Pediatric Attenuated Defibrillation Electrodes, Model 9730…Cardiac Science, Inc. · 2003
- 2 generations backK031987 Powerheart Aed G3, Model 9300Cardiac Science · 2003 · Recalled
- 1 generation backK040438 Powerheart Aed G3ACardiac Science, Inc. · 2004 · Recalled
- This deviceK102496 Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic…Cardiac Science Corporation · 2011
- Descendant · cites it directly · 1 of its ownK122758 Powerheart G5 AedCardiac Science Corporation · 2014
- Descendant · 2 generations on · 0 of its ownK143714 Powerheart G5 AEDCardiac Science Corporation · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K970741 | Powerheart Aecd | Cardiac Science, Inc. | 1997 | 1 |
| −6 | K982710 | Aecd Arrhythmia Detection Software | Cardiac Science, Inc. | 1998 | 1 |
| −5 | K993533 | Powerheart Aecd | Cardiac Science, Inc. | 2000 | 1 |
| −4 | K011901 | Firstsave Star Biphasic, Model 9210/9200 | Survivalink Corp. | 2002 | 2 |
| −3 | K022929 | Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed… | Cardiac Science, Inc. | 2003 | — |
| −2 | K031987 | Powerheart Aed G3, Model 9300 | Cardiac Science | 2003 | 33 |
| −1 | K040438 | Powerheart Aed G3A | Cardiac Science, Inc. | 2004 | 25 |
| 0 (this device) | K102496 | Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed… | Cardiac Science Corporation | 2011 | — |
| +1 | K122758 | Powerheart G5 Aed | Cardiac Science Corporation | 2014 | — |
| +2 | K143714 | Powerheart G5 AED | Cardiac Science Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MKJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031987 | Powerheart Aed G3, Model 9300Summary page 2…510(k) Date Cleared Identification Number Number Powerheart® AED G3 Semi- 9300E K03 1987 7/30/2003 Automatic Powerheart® AED 03 Automatic 9300A K040438 7/1/2004… | 2003 |
| * | K040438 | Powerheart Aed G3ASummary page 2…Powerheart® AED G3 Semi- 9300E K03 1987 7/30/2003 Automatic Powerheart® AED 03 Automatic 9300A K040438 7/1/2004 Powerheart® AED G3 Pro 9300P K040637 8/6/2004 Powerheart® AED… | 2004 |
| * | K040637 | Powerheart Aed G3 ProSummary page 2…Automatic Powerheart® AED 03 Automatic 9300A K040438 7/1/2004 Powerheart® AED G3 Pro 9300P K040637 8/6/2004 Powerheart® AED G3 Plus 9390A/E K052161 10/21/2005 D. Description of… | 2004 |
| * | K052161 | Powerheart Aed G3 (Model 9390E), Powerheart Aed G3 Automatic (Model 9390A)Summary page 2…8 7/1/2004 Powerheart® AED G3 Pro 9300P K040637 8/6/2004 Powerheart® AED G3 Plus 9390A/E K052161 10/21/2005 D. Description of the device The Powerheart® AED 03 family of devices (Model numbers 9300A1E, mode… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122758 | Powerheart G5 Aed | 2014 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 14, 2016 | Class II | Z-0829-2016 | Nonconforming Material/Component | Defibrillation electrodes may increase electrical impedance over time. If impedance becomes too high, the AED will fail the electrode self-test and it will not be Rescue Ready, the AED STATUS INDICATOR will be RED and the AED will beep.… |
| Jan 13, 2012 | Not classified | Z-1057-2012 | Process control | 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 fail during a rescue attempt, the AED… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 13 of the 17 ancestors have a recall of any class.
- Of its descendants, K122758 (Cardiac Science Corporation, 2014) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K031987.
How does its category compare?
All MKJ devicesMKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MKJ
48in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MKJ
156in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MKJ
1in 2025
Class I (23 since 2007) Class II/III not classified
Adverse event reports per year · MKJ
13,315in 2025
MAUDE reports naming product code MKJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 69 | 12 | 3,958 |
| 2008 | 13 | 141 | 24 | 4,752 |
| 2009 | 8 | 165 | 37 | 6,782 |
| 2010 | 4 | 250 | 35 | 7,399 |
| 2011 | 11 | 36 | 7 | 8,170 |
| 2012 | 10 | 197 | 5 (1) | 9,732 |
| 2013 | 7 | 191 | 4 | 14,955 |
| 2014 | 11 | 196 | 24 (15) | 15,399 |
| 2015 | 6 | 156 | 1 | 16,129 |
| 2016 | 0 | — | 2 (1) | 17,062 |
| 2017 | 4 | — | 6 (4) | 16,684 |
| 2018 | 20 | — | 3 | 16,591 |
| 2019 | 25 | — | 6 (2) | 16,861 |
| 2020 | 52 | — | 2 | 16,197 |
| 2021 | 41 | — | 4 | 16,300 |
| 2022 | 19 | — | 3 | 14,867 |
| 2023 | 24 | — | 11 | 13,766 |
| 2024 | 27 | — | 5 | 15,109 |
| 2025 | 48 | — | 1 | 13,315 |
| 2026 | 31 | — | 3 | — |
What is it indicated for?
The Powerheart® AED G3 family of devices 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…
Read the full statement (232 words)
The Powerheart® AED G3 family of devices 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 ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will change 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.
Additional information exclusive to the Power/wart®AED G3 Pro, Model 9300P: At the discretion of emergency care personnel, the G3Pro with EGG display enabled can also be used with Model 5111 EGG Patient Cable to display the rhythm of a responsive or breathing patient, regardless of age. The G3Pro and EGG Patient Cable system provides a non-diagnostic display for attended patient monitoring. While connected the G3Pro EGG Patient Gable, the G3Pro evaluates the patient's EGG and disables its shock capability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102496: Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed G3 Pro, Powerheart Aed G3 Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102496
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026