510(k) · Cleared
Recalled · 2011Powerheart Aed G3A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiac Science, Inc. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Jul 1, 2004 as substantially equivalent to K031987 (Cardiac Science, 2003) and 4 other predicates after a 133-day review. Its family tree reaches back 6 generations to 1997. 6 later devices descend from it. It has been recalled 25 times.
- Decided
- Jul 1, 2004
- Review
- 133 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 25
- Predicates
- 5
Its longest line of descent runs back 6 generations to K970741 (1997). 12 ancestors in all, the oldest K955628 (1996). 6 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK970741 Powerheart AecdCardiac Science, Inc. · 1997 · Recalled
- 5 generations backK982710 Aecd Arrhythmia Detection SoftwareCardiac Science, Inc. · 1998 · Recalled
- 4 generations backK993533 Powerheart AecdCardiac Science, Inc. · 2000 · Recalled
- 3 generations backK011901 Firstsave Star Biphasic, Model 9210/9200Survivalink Corp. · 2002 · Recalled
- 2 generations backK022929 Pediatric Attenuated Defibrillation Electrodes, Model 9730…Cardiac Science, Inc. · 2003
- 1 generation backK031987 Powerheart Aed G3, Model 9300Cardiac Science · 2003 · Recalled
- This deviceK040438 Powerheart Aed G3ACardiac Science, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK102496 Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic…Cardiac Science Corporation · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK122758 Powerheart G5 AedCardiac Science Corporation · 2014
- Descendant · 3 generations on · 0 of its ownK143714 Powerheart G5 AEDCardiac Science Corporation · 2015
- Descendant · cites it directly · 0 of its ownK141231 ZP9141, ZP9146Y, ZP9146W Non-Rechargeable BatteryZeller Power Products (Battery Beast, LLC) · 2014
- Descendant · cites it directly · 0 of its ownK120350 Extended Life BatteryAed Battery Exchange, LLC · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K102496Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed G3 Pro…Cardiac Science Corporation · 2011 · cites it directly2descendants
- K122758Powerheart G5 AedCardiac Science Corporation · 2014 · 2 generations on1descendant
- K143714Powerheart G5 AEDCardiac Science Corporation · 2015 · 3 generations on0descendants
- K141231ZP9141, ZP9146Y, ZP9146W Non-Rechargeable BatteryZeller Power Products (Battery Beast, LLC) · 2014 · cites it directly0descendants
- K120350Extended Life BatteryAed Battery Exchange, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K970741 | Powerheart Aecd | Cardiac Science, Inc. | 1997 | 1 |
| −5 | K982710 | Aecd Arrhythmia Detection Software | Cardiac Science, Inc. | 1998 | 1 |
| −4 | K993533 | Powerheart Aecd | Cardiac Science, Inc. | 2000 | 1 |
| −3 | K011901 | Firstsave Star Biphasic, Model 9210/9200 | Survivalink Corp. | 2002 | 2 |
| −2 | K022929 | Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed… | Cardiac Science, Inc. | 2003 | — |
| −1 | K031987 | Powerheart Aed G3, Model 9300 | Cardiac Science | 2003 | 33 |
| 0 (this device) | K040438 | Powerheart Aed G3A | Cardiac Science, Inc. | 2004 | — |
| +1 | K102496 | Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed… | Cardiac Science Corporation | 2011 | 2 |
| +2 | K122758 | Powerheart G5 Aed | Cardiac Science Corporation | 2014 | — |
| +3 | K143714 | Powerheart G5 AED | Cardiac Science Corporation | 2015 | — |
| +1 | K141231 | ZP9141, ZP9146Y, ZP9146W Non-Rechargeable Battery | Zeller Power Products (Battery Beast, LLC) | 2014 | — |
| +1 | K120350 | Extended Life Battery | Aed Battery Exchange, LLC | 2012 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 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? (5)
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 1…ivalent to the current Powerheart® AED and accessories in commercial distribution that was cleared under premarket 510(k) notifications K022929, K01 1901, 1,982710 and K031987. The reason for this premarket notification is to introduce a fully -automation version of the device_… | 2003 |
| * | K022929 | Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model…Summary page 1…device in this submission is equivalent to the current Powerheart® AED and accessories in commercial distribution that was cleared under premarket 510(k) notifications K022929, K01 1901, 1,982710 and K031987. The reason for this premarket notification is to introduce a fully -automation version of the… | 2003 |
| * | K011901 | Firstsave Star Biphasic, Model 9210/9200Summary page 1…this submission is equivalent to the current Powerheart® AED and accessories in commercial distribution that was cleared under premarket 510(k) notifications K022929, K01 1901, 1,982710 and K031987. The reason for this premarket notification is to introduce a fully -automation version of the device_… | 2002 |
| * | K982264 | Firstsave Biphasic Models 9200 and 9210Summary page 2…01/27/2003 Corporation (renamed Powerheart AED) K01 1901 02/01/2002 (Cardiac Science) K982264 01/25/1999 Medtronic Physio- LWEPAK CR PLUS AED KO 11144 12/03/2001 Control Corp. 16… | 1999 |
| * | K011144 | Lifepak 600 Automated External Defibrillator | 2001 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102496 | Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed G3 Pro… | 2011 | 2 |
| K141231 | ZP9141, ZP9146Y, ZP9146W Non-Rechargeable Battery | 2014 | 0 |
| K120350 | Extended Life Battery | 2012 | 0 |
| K082861 | Amco Replacement Battery for Powerheart Aed, Non-Rechargeable, Model 2L561; G3… | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 30, 2011 | Not classified | Z-3265-2011 | Device Design | 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 errors cause the device to enter into a… |
| Feb 3, 2010 | Not classified | Z-1248-2010 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Process control | Potential for devices not to deliver therapy |
| Nov 13, 2009 | Not classified | Z-0778-2010 | Process control | Potential for devices not to deliver therapy |
| Nov 13, 2009 | Not classified | Z-0766-2010 | Process control | Potential for devices not to deliver therapy |
| Nov 13, 2009 | Not classified | Z-0768-2010 | Process control | Potential for devices not to deliver therapy |
| Nov 13, 2009 | Not classified | Z-0769-2010 | Process control | Potential for devices not to deliver therapy |
| Nov 13, 2009 | Not classified | Z-0771-2010 | Process control | Potential for devices not to deliver therapy |
| Nov 13, 2009 | Not classified | Z-0775-2010 | Process control | Potential for devices not to deliver therapy |
| Nov 13, 2009 | Not classified | Z-0776-2010 | Process control | Potential for devices not to deliver therapy |
| Nov 13, 2009 | Not classified | Z-0777-2010 | Process control | Potential for devices not to deliver therapy |
| Nov 13, 2009 | Not classified | Z-0767-2010 | Process control | Potential for devices not to deliver therapy |
| Nov 13, 2009 | Not classified | Z-0770-2010 | Process control | Potential for devices not to deliver therapy |
| Nov 13, 2009 | Not classified | Z-0772-2010 | Process control | Potential for devices not to deliver therapy |
| Nov 13, 2009 | Not classified | Z-0773-2010 | Process control | Potential for devices not to deliver therapy |
| Nov 13, 2009 | Not classified | Z-0774-2010 | Process control | Potential for devices not to deliver therapy |
| Oct 13, 2008 | Not classified | Z-0921-2009 | Software design | Potential for AED to not deliver defibrillation therapy. |
| Jan 27, 2006 | Not classified | Z-0623-06 | Process control | 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 | Nonconforming Material/Component | 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's ability to delivery therapy. In the… |
The 5 latest of 25 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 8 of the 12 ancestors have a recall of any class.
- Of its descendants, K102496 (Cardiac Science Corporation, 2011) has gone furthest, with 2 descendants 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.
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 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…
Read the full statement (145 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040438 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040438: Powerheart Aed G3A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040438
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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