510(k) · Cleared
Recalled · 2011Aecd Arrhythmia Detection Software
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 10, 1998 as substantially equivalent to K970741 (Cardiac Science, Inc., 1997) after a 6-day review. Its family tree reaches back 1 generation to 1997. 14 later devices descend from it. It has been recalled once.
- Decided
- Aug 10, 1998
- Review
- 6 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970741 (1997). 14 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK970741 Powerheart AecdCardiac Science, Inc. · 1997 · Recalled
- This deviceK982710 Aecd Arrhythmia Detection SoftwareCardiac Science, Inc. · 1998
- Descendant · cites it directly · 13 of its ownK993533 Powerheart AecdCardiac Science, Inc. · 2000 · Recalled
- Descendant · 2 generations on · 11 of its ownK011901 Firstsave Star Biphasic, Model 9210/9200Survivalink Corp. · 2002 · Recalled
- Descendant · 3 generations on · 10 of its ownK022929 Pediatric Attenuated Defibrillation Electrodes, Model 9730…Cardiac Science, Inc. · 2003
- Descendant · 3 generations on · 8 of its ownK031987 Powerheart Aed G3, Model 9300Cardiac Science · 2003 · Recalled
- Descendant · 3 generations on · 6 of its ownK040438 Powerheart Aed G3ACardiac Science, Inc. · 2004 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K993533Powerheart AecdCardiac Science, Inc. · 2000 · cites it directly13descendants
- K011901Firstsave Star Biphasic, Model 9210/9200Survivalink Corp. · 2002 · 2 generations on11descendants
- K022929Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model…Cardiac Science, Inc. · 2003 · 3 generations on10descendants
- K031987Powerheart Aed G3, Model 9300Cardiac Science · 2003 · 3 generations on8descendants
- K040438Powerheart Aed G3ACardiac Science, Inc. · 2004 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970741 | Powerheart Aecd | Cardiac Science, Inc. | 1997 | 1 |
| 0 (this device) | K982710 | Aecd Arrhythmia Detection Software | Cardiac Science, Inc. | 1998 | — |
| +1 | K993533 | Powerheart Aecd | Cardiac Science, Inc. | 2000 | 1 |
| +2 | K011901 | Firstsave Star Biphasic, Model 9210/9200 | Survivalink Corp. | 2002 | 2 |
| +3 | K022929 | Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed… | Cardiac Science, Inc. | 2003 | — |
| +3 | K031987 | Powerheart Aed G3, Model 9300 | Cardiac Science | 2003 | 33 |
| +3 | K040438 | Powerheart Aed G3A | Cardiac Science, Inc. | 2004 | 25 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K970741 | Powerheart AecdSummary page 1…fication Name: Defibrillators, Automatic, External Identification of Predicate Device Company Unmodified Device 510(k) No. Date Cleared Cardiac Science Powerheart® AECD® K970741 Oct. 16, 1997 Device Description The Cardiac Science, Inc., AECD Arrhythmia Detection Software is simply the “arrhythmia detect… | 1997 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993533 | Powerheart Aecd | 2000 | 13 |
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?
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 AECD Arrhythmia Detection Software, when loaded into 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/K982710 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982710: Aecd Arrhythmia Detection Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982710
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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