510(k) Report

510(k) · Cleared

Recalled · Class I · 2020

Infant/Child Reduced Energy Electrodes

K022732510(k) TraditionalCleared Dec 13, 2002119-day reviewClass III21 CFR 870.5310Recalls 4 (2 Class I)

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

Medtronic Physio-Control Corp. · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on Dec 13, 2002 as substantially equivalent to K003819 (Agilent Technologies, Inc., 2001) after a 119-day review. Its family tree reaches back 1 generation to 2001. 1 of the 77 devices in its family, counting itself, has a Class I recall. 75 later devices descend from it. It has been recalled 4 times, including 2 Class I recalls.

Decided
Dec 13, 2002
Review
119 days
Class
Class III
Product code
MKJ
Recalls
4 (2 Class I)
Predicates
2

Its longest line of descent runs back 1 generation to K003819 (2001). 75 later devices descend from it, 3 citing it directly. 1 of the 77 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2004: 2 descendants cleared2012: 7 descendants cleared2011: 8 descendants cleared2010: 4 descendants cleared2005: 2 descendants cleared2006: 1 descendant cleared2009: 5 descendants cleared2008: 4 descendants cleared2013: 1 descendant cleared2015: 5 descendants cleared2016: 1 descendant cleared2014: 6 descendants cleared2017: 3 descendants cleared2020: 6 descendants cleared2018: 2 descendants cleared2021: 2 descendants cleared2023: 4 descendants cleared2019: 3 descendants cleared2022: 1 descendant cleared2024: 5 descendants cleared2026: 2 descendants cleared2025: 1 descendant clearedK003819 · Heartstream Attenuated Defibrillation Pads, Model M3870A · Agilent Technologies, Inc. · 2001 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 5 descendants3 generations forward: 12 descendants4 generations forward: 16 descendants5 generations forward: 14 descendants6 generations forward: 8 descendants7 generations forward: 14 descendants8 generations forward: 3 descendants K003819 · Heartstream Attenuated Defibrillation Pads, Model M3870A · Agilent Technologies, Inc. · 2001 · recalled0+5
  1. Root · 1 generation backK003819 Heartstream Attenuated Defibrillation Pads, Model M3870AAgilent Technologies, Inc. · 2001 · Recalled
  2. This deviceK022732 Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002
  3. Descendant · cites it directly · 72 of its ownK033474 Zoll Aed PlusZoll Medical Corp · 2004 · Recalled
  4. Descendant · 2 generations on · 64 of its ownK042007 Zoll E Series DefibrillatorZoll Medical Corp · 2005 · Recalled
  5. Descendant · 3 generations on · 27 of its ownK090989 Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp · 2009
  6. Descendant · 4 generations on · 24 of its ownK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
  7. Descendant · 2 generations on · 23 of its ownK041892 Zoll Aed Pro External DefibrillatorZOLL Medical Corporation · 2005

Showing 5 of 75 descendants. See all descendants

Descendants cleared per year

2004: 22005: 22006: 12008: 42009: 52010: 42011: 82012: 72013: 12014: 62015: 52016: 12017: 32018: 22019: 32020: 62021: 22022: 12023: 42024: 52025: 12026: 2
2004high 8 (2011) · low 0 (2007)2026

Most influential descendants

Showing 5 of 75 · See all
  • K033474Zoll Aed PlusZoll Medical Corp · 2004 · cites it directly72descendants
  • K042007Zoll E Series DefibrillatorZoll Medical Corp · 2005 · 2 generations on64descendants
  • K090989Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp · 2009 · 3 generations on27descendants
  • K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016 · 4 generations on24descendants
  • K041892Zoll Aed Pro External DefibrillatorZOLL Medical Corporation · 2005 · 2 generations on23descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003819Heartstream Attenuated Defibrillation Pads, Model M3870AAgilent Technologies, Inc.20014
0 (this device)K022732Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp.2002—
+1K033474Zoll Aed PlusZoll Medical Corp20041
+2K042007Zoll E Series DefibrillatorZoll Medical Corp20053
+3K090989Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp2009—
+4K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation2016—
+2K041892Zoll Aed Pro External DefibrillatorZOLL Medical Corporation2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200520
200610
200840
200950
201040
201180
201270
201310
201460
201550
201610
201730
201820
201930
202060
202120
202210
202340
202450
202510
202620
FIG. 1 — Lineage of K022732, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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.

1 device in this family has a Class I recall. 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK979301Medtronic Physio-Control Pediatric QUIK-COMBO electrodes
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 2
…e Infant / Child Reduced Energy Electrodes are substantially equivalent to those of the Medtronic Physio- Control Pediatric QUIK-COMBO electrodes, 51O(k) no. K979301, (cleared March 6, 1997) and the Heartstream Attenuated Defibrillation Pads, 510(k) no. KO03819 (cleared May 2, 2001…
*K003819Heartstream Attenuated Defibrillation Pads, Model M3870AAgilent Technologies, Inc.20014

Also cleared against K003819: 4 other devices →

What descends from it? (75)

See all 75

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

NumberDeviceApplicantDecidedDescendants
K033474Zoll Aed PlusZoll Medical Corp200472
K120536Heart Sync Pediatric Physio Aed PadHeart Sync, Inc.20120
K040479Pediatric Energy Reducer, Models Aed-10 and Aed-20Welch Allyn, Inc.20040

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 24, 2020Class IIZ-2360-2020Packaging change controlPackaging of infant child reduced energy electrodes was not properly sealed.
Apr 24, 2020Class IIZ-2359-2020Packaging change controlPackaging of infant child reduced energy electrodes was not properly sealed.
Oct 27, 2017Class IZ-0186-2018Process controlThe infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.
Oct 27, 2017Class IZ-0187-2018Process controlThe infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K033474 (Zoll Medical Corp, 2004) has gone furthest, with 72 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?

Use the Infant/Child defibrillation electrodes on an infant or child up to 8 years old or up to 25kg (551bs). Do not delay therapy to determine child’s exact age or weight. These electrodes are to be used only with LIFEPAK CR PLUS defibrillators and biphasic LIFEPAK 500 AEDs configured with a pink cable connector. The LIFEPAK CR PLUS and LIFEPAK 500 biphasic defibrillators are indicated for use on patients in cardiopulmonary arrest. The patient must be…

Read the full statement (143 words)

Use the Infant/Child defibrillation electrodes on an infant or child up to 8 years old or up to 25kg (551bs). Do not delay therapy to determine child’s exact age or weight.

These electrodes are to be used only with LIFEPAK CR PLUS defibrillators and biphasic LIFEPAK 500 AEDs configured with a pink cable connector.

The LIFEPAK CR PLUS and LIFEPAK 500 biphasic defibrillators are indicated for use on patients in cardiopulmonary arrest. The patient must be unconscious, not breathing normally, and showing no signs of circulation (for example, no pulse, and/or no coughing, no movement) before the device is used to analyze the patient’s ECG rhythm.

The LIFEPAK CR PLUS and LIFEPAK 500 biphasic defibrillators are intended to be used by personnel who have been trained on the device operation and in basic life support or other physician authorized emergency medical response system.

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
  • K022929Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model 9200/9210Cardiac Science, Inc. · 2003

More from Medtronic Physio-Control Corp.

8 FDA decisions under this applicant name. See the company

  • K040775Lifepak 12Medtronic Physio-Control Corp. · 20041 recall
  • K033275Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 20031 recall
  • K012274Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 200217 recalls
  • K011144Lifepak 600 Automated External DefibrillatorMedtronic Physio-Control Corp. · 20019 recalls
  • K012428Modification to: Lifepak 500 Automated External DefibrillatorMedtronic Physio-Control Corp. · 20012 recalls

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/K022732 · printed Nov 5, 2026

Cite this page

510(k) Report. “K022732: Infant/Child Reduced Energy Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022732

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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