510(k) Report

510(k) · Cleared

Cleared

Extended Life Battery

K120350510(k) TraditionalCleared Nov 1, 2012269-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

Aed Battery Exchange, LLC · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on Nov 1, 2012 as substantially equivalent to K031987 (Cardiac Science, 2003) and 11 other predicates after a 269-day review. Its family tree reaches back 7 generations to 1997.

Decided
Nov 1, 2012
Review
269 days
Class
Class III
Product code
MKJ
Recalls
None
Predicates
12

Its longest line of descent runs back 7 generations to K970741 (1997). 29 ancestors in all, the oldest K943301 (1995). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor2009: 1 other ancestor2005: 2 other ancestors2004: 2 other ancestors2002: 4 other ancestors1996: 2 other ancestors2008: 1 other ancestor2001: 3 other ancestors2000: 1 other ancestor1999: 1 other ancestor1995: 2 other ancestors1998: 1 other ancestor1997: 1 other ancestorK970741 · 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 · recalledK022929 · Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model 9200/9210 · Cardiac Science, Inc. · 2003K031987 · Powerheart Aed G3, Model 9300 · Cardiac Science · 2003 · recalledK040438 · Powerheart Aed G3A · Cardiac Science, Inc. · 2004 · recalled1995200020052010
Other ancestors, by generation 1 generation back: 10 other ancestors2 generations back: 9 other ancestors3 generations back: 3 other ancestors K040438 · Powerheart Aed G3A · Cardiac Science, Inc. · 2004 · recalledK031987 · Powerheart Aed G3, Model 9300 · Cardiac Science · 2003 · recalledK022929 · Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model 9200/9210 · Cardiac Science, Inc. · 2003K011901 · 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 · recalled−50
  1. Root · 7 generations backK970741 Powerheart AecdCardiac Science, Inc. · 1997 · Recalled
  2. 6 generations backK982710 Aecd Arrhythmia Detection SoftwareCardiac Science, Inc. · 1998 · Recalled
  3. 5 generations backK993533 Powerheart AecdCardiac Science, Inc. · 2000 · Recalled
  4. 4 generations backK011901 Firstsave Star Biphasic, Model 9210/9200Survivalink Corp. · 2002 · Recalled
  5. 3 generations backK022929 Pediatric Attenuated Defibrillation Electrodes, Model 9730…Cardiac Science, Inc. · 2003
  6. 2 generations backK031987 Powerheart Aed G3, Model 9300Cardiac Science · 2003 · Recalled
  7. 1 generation backK040438 Powerheart Aed G3ACardiac Science, Inc. · 2004 · Recalled
  8. This deviceK120350 Extended Life BatteryAed Battery Exchange, LLC · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K970741Powerheart AecdCardiac Science, Inc.19971
−6K982710Aecd Arrhythmia Detection SoftwareCardiac Science, Inc.19981
−5K993533Powerheart AecdCardiac Science, Inc.20001
−4K011901Firstsave Star Biphasic, Model 9210/9200Survivalink Corp.20022
−3K022929Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed…Cardiac Science, Inc.2003—
−2K031987Powerheart Aed G3, Model 9300Cardiac Science200333
−1K040438Powerheart Aed G3ACardiac Science, Inc.200425
0 (this device)K120350Extended Life BatteryAed Battery Exchange, LLC2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
199620
199710
199810
199910
200010
200130
200240
200420
200520
200810
200910
201110
FIG. 1 — Lineage of K120350, 1997–2012Source: 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.

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? (12)

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
*K031987Powerheart Aed G3, Model 9300
Summary page 2
…pany Device 510(k) # Date Cleared Cardiac Science Replacement Battery 9141 K03 1987 7/30/2003 K040438 7/1/2004 Cardiac Sci…
Cardiac Science200333
*K040438Powerheart Aed G3A
Summary page 2
…Cardiac Science Replacement Battery 9141 K03 1987 7/30/2003 K040438 7/1/2004 Cardiac Science Replacement Battery 9146 K03 1987 7/30/2003…
Cardiac Science, Inc.200425
*K955628Fore Runner External Defibrillator/Defibrillator Pads
Summary page 2
…K040438 7/1/2004 Philips Replacement Battery ForeRunner BTI K955628 9/10/1996 Philips Replacement Battery HeartStart K020715 11/8/2002…
Heartstream, Inc.1996—
*K020715Philips M5066A and M5068A
Summary page 2
…Philips Replacement Battery ForeRunner BTI K955628 9/10/1996 Philips Replacement Battery HeartStart K020715 11/8/2002 FRX, Onsite/HomeAED (M5070) K040904 9/16/2004…
Philips Medical Systems200212
*K040904Philips Heartstart Home Defibrillator, Model M5068A
Summary page 2
…Philips Replacement Battery HeartStart K020715 11/8/2002 FRX, Onsite/HomeAED (M5070) K040904 9/16/2004 K050004 2/25/2005 Philips…
Philips Medical Systems20047
*K050004Philips Heartstart FRX Defibrillator, Model 861304
Summary page 2
…FRX, Onsite/HomeAED (M5070) K040904 9/16/2004 K050004 2/25/2005 Philips Replacement Battery HeartStart K013425 1/14/2002…
Philips Medical Systems20057
*K013425Heartstream/Heartstart FR2 Aed Ecg Cable, Models M3860A, M3861A, M3840A, M3841A
Summary page 2
…K050004 2/25/2005 Philips Replacement Battery HeartStart K013425 1/14/2002 FR2 (M3863) KO051632 10/5/2005 Philips…
Philips Medical Systems200210
*K051632Philips Heartstart FR2+ Automated External Defibrillator, Models M3860A, M3861A, M3840A…
Summary page 2
…hilips Replacement Battery HeartStart K013425 1/14/2002 FR2 (M3863) KO051632 10/5/2005 Philips Replacement Battery HeartStart FR3 (989803150161…
Philips Medical Systems20057
*K111693Philips Heartstart FR3 Automated External Defibrillator
Summary page 2
…KO051632 10/5/2005 Philips Replacement Battery HeartStart FR3 (989803150161) K111693 l0/28/2011 Defibtech Replacement Battery DCF-200 K033 896 6/16/2004…
Philips Medical Systems20111
*K033896Defibtech Aed with Attenuated Defibrillation/Monitoring Pads, Models Ddu-100 with DDP-200P
Summary page 2
…FR3 (989803150161) K111693 l0/28/2011 Defibtech Replacement Battery DCF-200 K033 896 6/16/2004 K081259 6/15/2009 Physio Con…
Defibtech, LLC20041
*K081259Ddu-2300 Semiautomatic External Defibrillator and Accessories
Summary page 2
…Defibtech Replacement Battery DCF-200 K033 896 6/16/2004 K081259 6/15/2009 Physio Control Replacement Battery Lifepak 500 K955854 11/4/1996 5.6 Substa…
Defibtech, LLC2009—
*K955854Lifepak 500
Summary page 2
…K081259 6/15/2009 Physio Control Replacement Battery Lifepak 500 K955854 11/4/1996 5.6 Substantial Equivalence: The Green4Life Battery packs are re-celled battery packs of those identif…
Physio-Control Corp.19962

Also cleared against K031987: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 15 years and passes through 4 companies; a new generation was cleared every 12 months on median.
  • 20 of the 29 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K031987.

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. 2012, this device’s year, is highlighted.

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?

To provide power for the specific Automated External Defibrillators (AEDs) for which the original battery packs were designed and manufactured, in back-up and portable use.

Indications for use as stated in the FDA summary.

Also cleared against K031987

5 other devices cite the same predicate.

  • K141231ZP9141, ZP9146Y, ZP9146W Non-Rechargeable BatteryZeller Power Products (Battery Beast, LLC) · 2014
  • K102496Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed G3 Pro, Powerheart Aed G3 PlusCardiac Science Corporation · 20112 recalls
  • K082861Amco Replacement Battery for Powerheart Aed, Non-Rechargeable, Model 2L561; G3, Non-Rechargable, Model 7L561Amco International Manufacturing & Design, Inc. · 2008
  • K040637Powerheart Aed G3 ProCardiac Science, Inc. · 20048 recalls
  • K040438Powerheart Aed G3ACardiac Science, Inc. · 200425 recalls

More from Aed Battery Exchange, LLC

3 FDA decisions under this applicant name. See the company

  • P190013/S001DBP-1400-ABE and DBP-2003- ABEAed Battery Exchange, LLC · 2025
  • P190013AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)Aed Battery Exchange, LLC · 2021

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/K120350 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120350: Extended Life Battery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120350

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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