510(k) · Cleared
Recalled · 2010Powerheart 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 Corporation · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Sep 10, 2009 as substantially equivalent to K052161 (Cardiac Science, Inc., 2005) and 1 other predicate after a 72-day review. Its family tree reaches back 1 generation to 2001. It has been recalled 7 times.
- Decided
- Sep 10, 2009
- Review
- 72 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 1 generation to K010214 (2001). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK010214 Firstsave Biphasic Model #9200 and 9210Survivalink Corp. · 2001 · Recalled
- This deviceK091943 Powerheart Aed G3, Model 9390E, Powerheart Aed G3 Automatic, Model…Cardiac Science Corporation · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010214 | Firstsave Biphasic Model #9200 and 9210 | Survivalink Corp. | 2001 | 1 |
| 0 (this device) | K091943 | Powerheart Aed G3, Model 9390E, Powerheart Aed G3 Automatic, Model 9390A | Cardiac Science Corporation | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | K052161 | Powerheart Aed G3 (Model 9390E), Powerheart Aed G3 Automatic (Model 9390A)Summary page 2…ared with the predicate device. The Cardiac Science, Inc. Powerheart AED is substantially equivalent to the Powerheart AED cleared in K052161 and FirstSave STAR Biphasic AED cleared in K01 0214 in terms of indications for use, features… | 2005 |
| * | K010214 | Firstsave Biphasic Model #9200 and 9210Summary page 2…, Inc. Powerheart AED is substantially equivalent to the Powerheart AED cleared in K052161 and FirstSave STAR Biphasic AED cleared in K01 0214 in terms of indications for use, features and functions. Confidential… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class.
- 1 other device also cites its predicate K052161.
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. 2009, 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 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 (157 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 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091943: 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 6, 2026. https://510kreport.com/device/K091943
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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