510(k) · Cleared
Recalled · 2010Powerheart Aed G3 Pro
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 Aug 6, 2004 as substantially equivalent to K031987 (Cardiac Science, 2003) and 2 other predicates after a 149-day review. Its family tree reaches back 6 generations to 1997. 3 later devices descend from it. It has been recalled 8 times.
- Decided
- Aug 6, 2004
- Review
- 149 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 8
- Predicates
- 3
Its longest line of descent runs back 6 generations to K970741 (1997). 13 ancestors in all, the oldest K955628 (1996). 3 later devices descend from it, 1 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 deviceK040637 Powerheart Aed G3 ProCardiac 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
Most influential descendants
Showing 3 of 3 · 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
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) | K040637 | Powerheart Aed G3 Pro | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K031987 | Powerheart Aed G3, Model 9300Summary page 1…quivalent to the current Powerhearn®I AED and accessories in commercial distribution that was cleared under premarket 510(k) notifications K022929, KG) 1901, K982710 and K03 1987. The reason fbr this premarket notification is to iatruduce the semui-automratic… | 2003 |
| * | K014157 | HEARTSTREAMFR2 Aed with M3848A and M3849A, Models M3860A, M3861, M3840A, M3841A | 2002 |
| * | K013425 | Heartstream/Heartstart FR2 Aed Ecg Cable, Models M3860A, M3861A, M3840A, M3841ASummary page 2…07/30/2003 Philips Medical lleartstream FR2 KO 14157 01/17/2002 Systems K013425 01/14/2002 17.7: SUBSTANTIAL EQUIVALENCE The Powerheart® AED G3Pro covered by this submission is substantially equival… | 2002 |
What descends from it? (3)
1 later device cites 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 |
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. |
| Nov 12, 2004 | Not classified | Z-0400-05 | 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 8 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 1.0 years on median.
- 9 of the 13 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 G3 Pro, model 9300P, 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…
Read the full statement (219 words)
The Powerheart® AED G3 Pro, model 9300P, 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 Pro 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.
At the discretion of emergency care personnel, the G3Pro with ECG display enabled can also be used with the Model 5111 ECG Patient Cable to display the rhythm of a responsive or breathing patient, regardless of age. The G3Pro and ECG Patient Cable system provides a non-diagnostic display for attended patient monitoring. While connected the G3Pro ECG Patient Cable, the G3Pro evaluates the patient's ECG and disables its shock capability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040637 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040637: Powerheart Aed G3 Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040637
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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