510(k) · Cleared
Recalled · 2011Powerheart Cardiac Rhythm Module
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 Nov 16, 2001 as substantially equivalent to K993533 (Cardiac Science, Inc., 2000) after a 126-day review. Its family tree reaches back 3 generations to 1997. It has been recalled once.
- Decided
- Nov 16, 2001
- Review
- 126 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970741 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK970741 Powerheart AecdCardiac Science, Inc. · 1997 · Recalled
- 2 generations backK982710 Aecd Arrhythmia Detection SoftwareCardiac Science, Inc. · 1998 · Recalled
- 1 generation backK993533 Powerheart AecdCardiac Science, Inc. · 2000 · Recalled
- This deviceK012197 Powerheart Cardiac Rhythm ModuleCardiac Science, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K993533 | Powerheart AecdSummary page 1…assification 1. 870.5300 DC-defibrillator 2. 870.5550 External Transcutaneous Cardiac Pacemaker (Noninvasive) 3. ClassIII 74 MJK 10.5 Predicate Device Powerheart® AECD®, K993533 10.6 Description of Device The Powerheart Cardiac Rhythm Module (CRM) is a compact, lightweight, automatic external cardioverter… | 2000 |
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 |
|---|---|---|---|---|
| Jun 29, 2011 | Not classified | Z-2917-2011 | Nonconforming Material/Component | Cardiac Science Corporation (CSC) intent to end service support and discontinue accessory sales of Powerheart G2 Automated External Defibrillators. Customers are recommended to choose a replacement AED prior to the current AED displaying… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
- 3 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K993533.
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 Cardiac Rhythm Module (CRM) is intended to acquire the ECG rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of patients who are at risk of sudden cardiac arrest. The device is intended to be used in medically supervised environments by trained personnel, in which patients are under the direct care of physicians and/or medical persons authorized by the state, province or country regulations in which…
Read the full statement (302 words)
The Powerheart Cardiac Rhythm Module (CRM) is intended to acquire the ECG rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of patients who are at risk of sudden cardiac arrest. The device is intended to be used in medically supervised environments by trained personnel, in which patients are under the direct care of physicians and/or medical persons authorized by the state, province or country regulations in which they practice. The Powerheart CRM can be used in three modes: fully automatic mode, advisory mode or manual mode and includes a pacer which allows an operator to deliver external stimuli for temporary transcutaneous cardiac pacing. The Powerheart has previously undergone clinical testing on adults which support the safety and effectiveness of using the device on patients at risk of sudden cardiac arrest who are at least 8 years of age. The device is not classified as a wearable external defibrillator and is not intended for use in the home environment.
Fully Automatic Mode
In this mode, the device continuously monitors the patient’s ECG rhythm, detects shockable ventricular tachyarrhythmias and automatically provides defibrillation therapy for the treatment of sudden cardiac arrest.
Advisory (AED) Mode
In this mode, the device continuously monitors the patient’s ECG rhythm, detects shockable ventricular tachyarrhythmias and advises the operator to press the shock button to deliver defibrillation therapy for the treatment of sudden cardiac arrest.
Manual Mode
In this mode, as is the case with all standard manual defibrillators, the operator manually selects the energy setting, manually selects the charge button, determines if the patient has a shockable ventricular tachyarrhythmia and decides when to manually deliver defibrillation therapy.
Pacing
The device includes a non-invasive external pacer that allows a physician and/or trained medical person to provide temporary external cardiac pacing for patients with symptomatic bradycardia or asystole.
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/K012197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012197: Powerheart Cardiac Rhythm Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012197
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026