510(k) Report

510(k) · Cleared

Cleared

Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model 9200/9210

K022929510(k) TraditionalCleared Jan 27, 2003145-day reviewClass III21 CFR 870.5310

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cardiac Science, Inc. · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on Jan 27, 2003 as substantially equivalent to K003819 (Agilent Technologies, Inc., 2001) and 1 other predicate after a 145-day review. Its family tree reaches back 4 generations to 1997. 10 later devices descend from it.

Decided
Jan 27, 2003
Review
145 days
Class
Class III
Product code
MKJ
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K970741 (1997). 6 ancestors in all. 10 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2003: 1 descendant cleared2007: 1 descendant cleared2004: 2 descendants cleared2014: 2 descendants cleared2011: 1 descendant cleared2012: 1 descendant cleared2008: 1 descendant cleared2015: 1 descendant clearedK970741 · Powerheart Aecd · Cardiac Science, Inc. · 1997 · recalledK982710 · Aecd Arrhythmia Detection Software · Cardiac Science, Inc. · 1998 · recalledK993533 · Powerheart Aecd · Cardiac Science, Inc. · 2000 · recalledK011901 · Firstsave Star Biphasic, Model 9210/9200 · Survivalink Corp. · 2002 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 6 descendants K011901 · Firstsave Star Biphasic, Model 9210/9200 · Survivalink Corp. · 2002 · recalledK993533 · Powerheart Aecd · Cardiac Science, Inc. · 2000 · recalledK982710 · Aecd Arrhythmia Detection Software · Cardiac Science, Inc. · 1998 · recalledK970741 · Powerheart Aecd · Cardiac Science, Inc. · 1997 · recalled0
  1. Root · 4 generations backK970741 Powerheart AecdCardiac Science, Inc. · 1997 · Recalled
  2. 3 generations backK982710 Aecd Arrhythmia Detection SoftwareCardiac Science, Inc. · 1998 · Recalled
  3. 2 generations backK993533 Powerheart AecdCardiac Science, Inc. · 2000 · Recalled
  4. 1 generation backK011901 Firstsave Star Biphasic, Model 9210/9200Survivalink Corp. · 2002 · Recalled
  5. This deviceK022929 Pediatric Attenuated Defibrillation Electrodes, Model 9730…Cardiac Science, Inc. · 2003
  6. Descendant · cites it directly · 8 of its ownK031987 Powerheart Aed G3, Model 9300Cardiac Science · 2003 · Recalled
  7. Descendant · cites it directly · 6 of its ownK040438 Powerheart Aed G3ACardiac Science, Inc. · 2004 · Recalled
  8. Descendant · 2 generations on · 3 of its ownK040637 Powerheart Aed G3 ProCardiac Science, Inc. · 2004 · Recalled
  9. Descendant · 2 generations on · 2 of its ownK102496 Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic…Cardiac Science Corporation · 2011 · Recalled
  10. Descendant · cites it directly · 1 of its ownK122758 Powerheart G5 AedCardiac Science Corporation · 2014

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2003: 12004: 22007: 12008: 12011: 12012: 12014: 22015: 1
2003high 2 (2004) · low 0 (2005)2026

Most influential descendants

Showing 5 of 10 · See all
  • K031987Powerheart Aed G3, Model 9300Cardiac Science · 2003 · cites it directly8descendants
  • K040438Powerheart Aed G3ACardiac Science, Inc. · 2004 · cites it directly6descendants
  • K040637Powerheart Aed G3 ProCardiac Science, Inc. · 2004 · 2 generations on3descendants
  • K102496Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed G3 Pro…Cardiac Science Corporation · 2011 · 2 generations on2descendants
  • K122758Powerheart G5 AedCardiac Science Corporation · 2014 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K970741Powerheart AecdCardiac Science, Inc.19971
−3K982710Aecd Arrhythmia Detection SoftwareCardiac Science, Inc.19981
−2K993533Powerheart AecdCardiac Science, Inc.20001
−1K011901Firstsave Star Biphasic, Model 9210/9200Survivalink Corp.20022
0 (this device)K022929Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed…Cardiac Science, Inc.2003—
+1K031987Powerheart Aed G3, Model 9300Cardiac Science200333
+1K040438Powerheart Aed G3ACardiac Science, Inc.200425
+2K040637Powerheart Aed G3 ProCardiac Science, Inc.20048
+2K102496Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed…Cardiac Science Corporation20112
+1K122758Powerheart G5 AedCardiac Science Corporation2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200420
200710
200810
201110
201210
201420
201510
FIG. 1 — Lineage of K022929, 1997–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K003819Heartstream Attenuated Defibrillation Pads, Model M3870AAgilent Technologies, Inc.20014
*K011901Firstsave Star Biphasic, Model 9210/9200Survivalink Corp.20022

Also cleared against K003819: 4 other devices →

What descends from it? (10)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K031987Powerheart Aed G3, Model 9300Cardiac Science20038
K040438Powerheart Aed G3ACardiac Science, Inc.20046
K122758Powerheart G5 AedCardiac Science Corporation20141
K072430Zoll Pedipadz Reduced Energy ElectrodeZOLL Medical Corporation20070

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
  • 6 of the 6 ancestors have a recall of any class.
  • Of its descendants, K031987 (Cardiac Science, 2003) has gone furthest, with 8 descendants of its own.
  • 4 other devices also cite its predicate K003819.

How does its category compare?

All MKJ devices

MKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MKJ

48in 2025

2007: 72008: 132009: 82010: 42011: 112012: 102013: 72014: 112015: 62017: 42018: 202019: 252020: 522021: 412022: 192023: 242024: 272025: 482026 (partial year): 31
2007high 52 (2020) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MKJ

156in 2015

2007: 69 days median2008: 141 days median2009: 165 days median2010: 250 days median2011: 36 days median2012: 197 days median2013: 191 days median2014: 196 days median2015: 156 days median
2007high 250 (2010) · low 36 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MKJ

1in 2025

2007: 122008: 242009: 372010: 352011: 72012: 5, 1 Class I2013: 42014: 24, 15 Class I2015: 12016: 2, 1 Class I2017: 6, 4 Class I2018: 32019: 6, 2 Class I2020: 22021: 42022: 32023: 112024: 52025: 12026 (partial year): 3
2007high 37 (2009) · low 1 (2015)2026

Class I (23 since 2007) Class II/III not classified

Adverse event reports per year · MKJ

13,315in 2025

2007: 3,9582008: 4,7522009: 6,7822010: 7,3992011: 8,1702012: 9,7322013: 14,9552014: 15,3992015: 16,1292016: 17,0622017: 16,6842018: 16,5912019: 16,8612020: 16,1972021: 16,3002022: 14,8672023: 13,7662024: 15,1092025: 13,315
2007high 17,062 (2016) · low 3,958 (2007)2025

MAUDE reports naming product code MKJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007769123,958
200813141244,752
20098165376,782
20104250357,399
2011113678,170
2012101975 (1)9,732
20137191414,955
20141119624 (15)15,399
20156156116,129
20160—2 (1)17,062
20174—6 (4)16,684
201820—316,591
201925—6 (2)16,861
202052—216,197
202141—416,300
202219—314,867
202324—1113,766
202427—515,109
202548—113,315
202631—3—

What is it indicated for?

The Powerheart AED is intended for use 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…

Read the full statement (143 words)

The Powerheart AED is intended for use 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 tachyarrythmia recurs, the device will charge automatically and advise the operator to deliver therapy.

When the patient is a child or infant is up to 8 years of age, or up to 55 lbs (25kg), the Powerheart AED 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.

Indications for use as stated in the FDA summary.

Also cleared against K003819

4 other devices cite the same predicate.

  • K120536Heart Sync Pediatric Physio Aed PadHeart Sync, Inc. · 2012
  • K111693Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems · 20111 recall
  • K033896Defibtech Aed with Attenuated Defibrillation/Monitoring Pads, Models Ddu-100 with DDP-200PDefibtech, LLC · 20041 recall
  • K022732Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 20022 Class I recalls

More from Cardiac Science, Inc.

10 FDA decisions under this applicant name. See the company

  • K052316Powerheart EcdCardiac Science, Inc. · 2006
  • K052161Powerheart Aed G3 (Model 9390E), Powerheart Aed G3 Automatic (Model 9390A)Cardiac Science, Inc. · 200523 recalls
  • K040637Powerheart Aed G3 ProCardiac Science, Inc. · 20048 recalls
  • K040438Powerheart Aed G3ACardiac Science, Inc. · 200425 recalls
  • K022210Multifunctional Electrode Models 9640, 9650Cardiac Science, Inc. · 2002

Recent decisions in MKJ

The MKJ category page

  • P160015/S029AED 3 Defibrillator with Uni-PadzZOLL Medical Corporation · 2026
  • P160022/S056ZOLL R Series Monitor/DefibrillatorZOLL Medical Corporation · 2026
  • P160022/S054X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode…ZOLL Medical Corporation · 2026
  • P160026/S074Lifepak 1000 Defibrillator, Lifepak 20 Defibrillator/ Monitor, Lifepak 20E Defibrillator/ Monitor, Lifepak…Physio-Control, Inc. · 2026
  • P160026/S073LIFEPAK® 15 monitor/defibrillatorPhysio-Control, Inc. · 2026

https://510kreport.com/device/K022929 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022929: Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model 9200/9210.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022929

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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