510(k) · Cleared
Recalled · 2011Powerheart Aecd
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 Jan 24, 2000 as substantially equivalent to K970741 (Cardiac Science, Inc., 1997) and 1 other predicate after a 97-day review. Its family tree reaches back 2 generations to 1997. 13 later devices descend from it. It has been recalled once.
- Decided
- Jan 24, 2000
- Review
- 97 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K970741 (1997). 13 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK970741 Powerheart AecdCardiac Science, Inc. · 1997 · Recalled
- 1 generation backK982710 Aecd Arrhythmia Detection SoftwareCardiac Science, Inc. · 1998 · Recalled
- This deviceK993533 Powerheart AecdCardiac Science, Inc. · 2000
- Descendant · cites it directly · 11 of its ownK011901 Firstsave Star Biphasic, Model 9210/9200Survivalink Corp. · 2002 · Recalled
- Descendant · 2 generations on · 10 of its ownK022929 Pediatric Attenuated Defibrillation Electrodes, Model 9730…Cardiac Science, Inc. · 2003
- Descendant · 2 generations on · 8 of its ownK031987 Powerheart Aed G3, Model 9300Cardiac Science · 2003 · Recalled
- Descendant · 2 generations on · 6 of its ownK040438 Powerheart Aed G3ACardiac Science, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 3 of its ownK040637 Powerheart Aed G3 ProCardiac Science, Inc. · 2004 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K011901Firstsave Star Biphasic, Model 9210/9200Survivalink Corp. · 2002 · cites it directly11descendants
- K022929Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model…Cardiac Science, Inc. · 2003 · 2 generations on10descendants
- K031987Powerheart Aed G3, Model 9300Cardiac Science · 2003 · 2 generations on8descendants
- K040438Powerheart Aed G3ACardiac Science, Inc. · 2004 · 2 generations on6descendants
- K040637Powerheart Aed G3 ProCardiac Science, Inc. · 2004 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970741 | Powerheart Aecd | Cardiac Science, Inc. | 1997 | 1 |
| −1 | K982710 | Aecd Arrhythmia Detection Software | Cardiac Science, Inc. | 1998 | 1 |
| 0 (this device) | K993533 | Powerheart Aecd | Cardiac Science, Inc. | 2000 | — |
| +1 | 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 | — |
| +2 | K031987 | Powerheart Aed G3, Model 9300 | Cardiac Science | 2003 | 33 |
| +2 | K040438 | Powerheart Aed G3A | Cardiac Science, Inc. | 2004 | 25 |
| +3 | K040637 | Powerheart Aed G3 Pro | Cardiac Science, Inc. | 2004 | 8 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 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? (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 |
|---|---|---|---|
| * | K970741 | Powerheart AecdSummary page 1…ng “C™ Phone:; 949/587-0357, ext. 238 Irvine, CA 92614 Trade Name Common/Classification Name Powerheart® AECD® ) Defibrillator, Automatic, External Powerheart® AECD® (K970741). The Powerheart monitors a patient’s cardiac electrical activity and detects and treats ventricular tachyarrthythmias. The pati… | 1997 |
| * | K982710 | Aecd Arrhythmia Detection SoftwareSummary page 2…ate Device Candidate Device Primary Powerheart proprictary AECD® Same Component Arrhythmia Detection Software (cleared under K970741 and also cleared separately under K982710) Major 11. defibrillator Same Components 12. defibrillation electrodes 13. ECG electrodes (off-the- shelf) 14. patient cable… | 1998 |
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K011901 (Survivalink Corp., 2002) has gone furthest, with 11 descendants of its own.
- 1 other device also cites its predicate K970741.
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 AECD is intended to acquire the electrocardiograph rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of in-hospital patients who are at risk of Sudden Cardiac Arrest.
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/K993533 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993533: Powerheart Aecd.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993533
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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