510(k) · Cleared
ClearedPowerheart G5 AED
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 May 4, 2015 as substantially equivalent to K122758 (Cardiac Science Corporation, 2014) and 1 other predicate after a 126-day review. Its family tree reaches back 9 generations to 1997. 1 of the 27 devices in its family, counting itself, has a Class I recall.
- Decided
- May 4, 2015
- Review
- 126 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K970741 (1997). 26 ancestors in all, the oldest K914955 (1992). No later device cites it as a predicate yet. 1 of the 27 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK970741 Powerheart AecdCardiac Science, Inc. · 1997 · Recalled
- 5 generations between
- 3 generations backK040438 Powerheart Aed G3ACardiac Science, Inc. · 2004 · Recalled
- 2 generations backK102496 Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic…Cardiac Science Corporation · 2011 · Recalled
- 1 generation backK122758 Powerheart G5 AedCardiac Science Corporation · 2014
- This deviceK143714 Powerheart G5 AEDCardiac Science Corporation · 2015
Show all 9 generations
- Root · 9 generations backK970741 Powerheart AecdCardiac Science, Inc. · 1997 · Recalled
- 8 generations backK982710 Aecd Arrhythmia Detection SoftwareCardiac Science, Inc. · 1998 · Recalled
- 7 generations backK993533 Powerheart AecdCardiac Science, Inc. · 2000 · Recalled
- 6 generations backK011901 Firstsave Star Biphasic, Model 9210/9200Survivalink Corp. · 2002 · Recalled
- 5 generations backK022929 Pediatric Attenuated Defibrillation Electrodes, Model 9730…Cardiac Science, Inc. · 2003
- 4 generations backK031987 Powerheart Aed G3, Model 9300Cardiac Science · 2003 · Recalled
- 3 generations backK040438 Powerheart Aed G3ACardiac Science, Inc. · 2004 · Recalled
- 2 generations backK102496 Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic…Cardiac Science Corporation · 2011 · Recalled
- 1 generation backK122758 Powerheart G5 AedCardiac Science Corporation · 2014
- This deviceK143714 Powerheart G5 AEDCardiac Science Corporation · 2015
Class I recalls in this family
- K022732 Infant/Child Reduced Energy Electrodes4 generations back · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K970741 | Powerheart Aecd | Cardiac Science, Inc. | 1997 | 1 |
| −8 | K982710 | Aecd Arrhythmia Detection Software | Cardiac Science, Inc. | 1998 | 1 |
| −7 | K993533 | Powerheart Aecd | Cardiac Science, Inc. | 2000 | 1 |
| −6 | K011901 | Firstsave Star Biphasic, Model 9210/9200 | Survivalink Corp. | 2002 | 2 |
| −5 | K022929 | Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed… | Cardiac Science, Inc. | 2003 | — |
| −4 | K031987 | Powerheart Aed G3, Model 9300 | Cardiac Science | 2003 | 33 |
| −3 | K040438 | Powerheart Aed G3A | Cardiac Science, Inc. | 2004 | 25 |
| −2 | K102496 | Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed… | Cardiac Science Corporation | 2011 | 2 |
| −1 | K122758 | Powerheart G5 Aed | Cardiac Science Corporation | 2014 | — |
| 0 (this device) | K143714 | Powerheart G5 AED | Cardiac Science Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 1 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K122758 | Powerheart G5 AedSummary page 4…& Identification of the predicate devices to which substantial equivalence is being claimed Company Cardiac Science Corporation Device Powerheart® AED G35 510(k) number K122758 Date cleared February 12, 2014 Company ZOLL Medical Corporation Device Zoll AED Plus with CPR-D Padz 510(k) number K120406 Date… | 2014 |
| * | K120406 | Zoll Fully Automatic Aed PlusSummary page 4…ation Device Powerheart® AED G35 510(k) number K122758 Date cleared February 12, 2014 Company ZOLL Medical Corporation Device Zoll AED Plus with CPR-D Padz 510(k) number K120406 Date cleared October 26, 2012 K143714 Page 2 of 4 Description of the device The Powerheart® G5 AED is a portab… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K022732Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · 4 generations back · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 17 of the 26 ancestors have a recall of any class; 1 has a Class I recall.
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. 2015, 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 G5 Automated External Defibrillator (AED) is intended to be used by persons who have been trained in its operation. The user should be trained in basic life support or other physician-authorized emergency medical response. An AED is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing or not breathing normally. Post-resuscitation, if the patient is breathing, the AED should…
Read the full statement (204 words)
The G5 Automated External Defibrillator (AED) is intended to be used by persons who have been trained in its operation. The user should be trained in basic life support or other physician-authorized emergency medical response.
An AED is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing or not breathing normally. Post-resuscitation, if the patient 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 a shock, or for an automatic AED, automatically deliver a shock if needed.
When a patient is a child up to 8 years of age, or up to 25kg (55 1bs), the AED should be used with the Pediatric Defibrillation Pads. The therapy should not be delayed to determine the patient's exact age or weight.
The optional CPR Device offers CPR performance feedback to aid a trained rescuer by providing compression rate and depth performance feedback through audio prompting. The CPR Device is indicated for use on cardiac arrest patients 8 years of age or older, or who weigh more than 25 kg (55 Ibs).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143714 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143714: Powerheart G5 AED.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143714
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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