510(k) · Cleared
Recalled · 2011Powerheart Aed G3 (Model 9390E), Powerheart Aed G3 Automatic (Model 9390A)
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 Oct 21, 2005 after a 73-day review. The FDA summary names its predicate without a number. 4 later devices descend from it. It has been recalled 23 times.
- Decided
- Oct 21, 2005
- Review
- 73 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 23
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK052161 Powerheart Aed G3 (Model 9390E), Powerheart Aed G3 Automatic (Model…Cardiac Science, Inc. · 2005
- 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 ownK091943 Powerheart Aed G3, Model 9390E, Powerheart Aed G3 Automatic, Model…Cardiac Science Corporation · 2009 · Recalled
Most influential descendants
Showing 4 of 4 · 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
- K091943Powerheart Aed G3, Model 9390E, Powerheart Aed G3 Automatic, Model 9390ACardiac Science Corporation · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052161 | Powerheart Aed G3 (Model 9390E), Powerheart Aed G3 Automatic (Model 9390A) | Cardiac Science, Inc. | 2005 | — |
| +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 | K091943 | Powerheart Aed G3, Model 9390E, Powerheart Aed G3 Automatic, Model 9390A | Cardiac Science Corporation | 2009 | 7 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | — | Powerheart® AED G3 Named without a submission number | |
| * | — | Powerheart® AED G3 Automatic Named without a submission number |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-0922-2009 | Software design | Potential for AED to not deliver defibrillation therapy. |
The 5 latest of 23 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K102496 (Cardiac Science Corporation, 2011) has gone furthest, with 2 descendants of its own.
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 G3 and the Powerheart® AED G3 Automatic devices are 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…
Read the full statement (158 words)
The Powerheart® AED G3 and the Powerheart® AED G3 Automatic devices are 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 (G3) or automatically deliver the charge (G3 Automatic).
When a 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052161 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052161: Powerheart Aed G3 (Model 9390E), Powerheart Aed G3 Automatic (Model 9390A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052161
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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