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 Feb 12, 2014 as substantially equivalent to K102496 (Cardiac Science Corporation, 2011) and 2 other predicates after a 520-day review. Its family tree reaches back 8 generations to 1997. 1 later device descends from it.
- Decided
- Feb 12, 2014
- Review
- 520 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K970741 (1997). 21 ancestors in all, the oldest K914955 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK970741 Powerheart AecdCardiac Science, Inc. · 1997 · Recalled
- 7 generations backK982710 Aecd Arrhythmia Detection SoftwareCardiac Science, Inc. · 1998 · Recalled
- 6 generations backK993533 Powerheart AecdCardiac Science, Inc. · 2000 · Recalled
- 5 generations backK011901 Firstsave Star Biphasic, Model 9210/9200Survivalink Corp. · 2002 · Recalled
- 4 generations backK022929 Pediatric Attenuated Defibrillation Electrodes, Model 9730…Cardiac Science, Inc. · 2003
- 3 generations backK031987 Powerheart Aed G3, Model 9300Cardiac Science · 2003 · Recalled
- 2 generations backK040438 Powerheart Aed G3ACardiac Science, Inc. · 2004 · Recalled
- 1 generation backK102496 Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic…Cardiac Science Corporation · 2011 · Recalled
- This deviceK122758 Powerheart G5 AedCardiac Science Corporation · 2014
- Descendant · cites it directly · 0 of its ownK143714 Powerheart G5 AEDCardiac Science Corporation · 2015
Most influential descendants
Showing 1 of 1 · See all- K143714Powerheart G5 AEDCardiac Science Corporation · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K970741 | Powerheart Aecd | Cardiac Science, Inc. | 1997 | 1 |
| −7 | K982710 | Aecd Arrhythmia Detection Software | Cardiac Science, Inc. | 1998 | 1 |
| −6 | K993533 | Powerheart Aecd | Cardiac Science, Inc. | 2000 | 1 |
| −5 | K011901 | Firstsave Star Biphasic, Model 9210/9200 | Survivalink Corp. | 2002 | 2 |
| −4 | K022929 | Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed… | Cardiac Science, Inc. | 2003 | — |
| −3 | K031987 | Powerheart Aed G3, Model 9300 | Cardiac Science | 2003 | 33 |
| −2 | K040438 | Powerheart Aed G3A | Cardiac Science, Inc. | 2004 | 25 |
| −1 | K102496 | Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed… | Cardiac Science Corporation | 2011 | 2 |
| 0 (this device) | K122758 | Powerheart G5 Aed | Cardiac Science Corporation | 2014 | — |
| +1 | 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 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K102496 | Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed G3 Pro…Summary page 1…Cardiac Science Corporation Device Powerheart®)AED 03 Model number 9300A/E, 9390A/E 5 10O(k) number K 102496 Date cleared June 9, 2011 Device Defibrillation Electrodes Model number… | 2011 |
| * | K082090 | 9131 Defibrillation ElectrodesSummary page 1…2496 Date cleared June 9, 2011 Device Defibrillation Electrodes Model number 9131 5 10O(k) number K082090 Clearance date December 12, 2008 Device Pediatric Attenuated Defibrillation Electrodes… | 2008 |
| * | K022929 | Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model…Summary page 1…December 12, 2008 Device Pediatric Attenuated Defibrillation Electrodes Model number 9730 5 10O(k) number K022929 Clearance date September 11, 2002 K122758… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143714 | Powerheart G5 AED | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 15 of the 21 ancestors have a recall of any class.
- Of its descendants, K143714 (Cardiac Science Corporation, 2015) has gone furthest, with 0 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. 2014, 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 (154 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 Ibs), 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122758: 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/K122758
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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