510(k) · Cleared
Recalled · 2010Modification to Powerheart Ecd
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 15, 2006 as substantially equivalent to K052316 (Cardiac Science, Inc., 2006) after a 40-day review. Its family tree reaches back 1 generation to 2006. It has been recalled 2 times.
- Decided
- May 15, 2006
- Review
- 40 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052316 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK052316 Powerheart EcdCardiac Science, Inc. · 2006
- This deviceK060934 Modification to Powerheart EcdCardiac Science Corporation · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052316 | Powerheart Ecd | Cardiac Science, Inc. | 2006 | — |
| 0 (this device) | K060934 | Modification to Powerheart Ecd | Cardiac Science Corporation | 2006 | — |
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? (1)
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 |
|---|---|---|---|
| * | K052316 | Powerheart EcdSummary page 1…heart ECD TM manufactured by Cardiac Device(s): Science, Inc is substantially equivalent to the Cardiac Science Powerheart ECD - K052316 (11312006) Device The Powerheart® ECD is a defibrillator/monitor/ Description: pacemaker intende… | 2006 |
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 |
|---|---|---|---|---|
| Apr 28, 2010 | Not classified | Z-0589-2011 | Nonconforming Material/Component | Some units may be non-operational during a rescue, due to a defective PCB interconnect on traces connected to the reed relay. This will result in an inability to analyze the patient's heart rhythm or deliver therapy during a rescue. |
| Oct 15, 2009 | Not classified | Z-1683-2010 | Other | The Operators Manual may not have adequate information to clearly explain some device behaviors. Pressing and holding down the Charge or Shock button on the Responder 2000 for more than 5 seconds causes a "Button Stuck" error. With the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no 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.
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 ECD defibrillator system is intended to be used by personnel who have been trained in its operation. The Powerheart ECD is indicated for the termination of certain fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and in relatively stable patients…
Read the full statement (178 words)
The Powerheart ECD defibrillator system is intended to be used by personnel who have been trained in its operation.
The Powerheart ECD is indicated for the termination of certain fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.
The semi-automatic advisory mode is for use in cardiac arrest in patients of at least 8 years of age. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm.
The Powerheart ECD 3-lead and 5-lead ECG monitoring allows for identification or interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate.
The Powerheart ECD noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole.
The Powerheart ECD pulse oximetry is intended for the continuous external monitoring of arterial oxygen saturation and pulse rate and is indicated for use in any patient who is at risk of developing hypoxemia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060934 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060934: Modification to Powerheart Ecd.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060934
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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