510(k) Report

510(k) · Cleared

Recalled · 2011

Sentry Semiautomatic External Defibrillator; External Defibrillation Pads (Electrodes) DDP-100; Battery Pack 1200MAH; BA

K013896510(k) TraditionalCleared Jun 19, 2002208-day reviewClass III21 CFR 870.5310Recalls 5

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

Defibtech, LLC · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on Jun 19, 2002 as substantially equivalent to K955628 (Heartstream, Inc., 1996) and 1 other predicate after a 208-day review. Its family tree reaches back 1 generation to 1996. 6 later devices descend from it. It has been recalled 5 times.

Decided
Jun 19, 2002
Review
208 days
Class
Class III
Product code
MKJ
Recalls
5
Predicates
2

Its longest line of descent runs back 1 generation to K955628 (1996). 2 ancestors in all. 6 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2008: 1 descendant cleared2009: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2012: 2 descendants clearedK955628 · Fore Runner External Defibrillator/Defibrillator Pads · Heartstream, Inc. · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 3 descendants K955628 · Fore Runner External Defibrillator/Defibrillator Pads · Heartstream, Inc. · 19960
  1. Root · 1 generation backK955628 Fore Runner External Defibrillator/Defibrillator PadsHeartstream, Inc. · 1996
  2. This deviceK013896 Sentry Semiautomatic External Defibrillator; External Defibrillation…Defibtech, LLC · 2002
  3. Descendant · cites it directly · 3 of its ownK081259 Ddu-2300 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2009
  4. Descendant · 2 generations on · 0 of its ownK131525 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2014
  5. Descendant · cites it directly · 0 of its ownK113787 Ddu-120 Fully Automatic External Defibrillator and AccessoriesDefibtech, LLC · 2013
  6. Descendant · 2 generations on · 0 of its ownK121853 Ddu-2400/2450 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2012
  7. Descendant · 2 generations on · 0 of its ownK120350 Extended Life BatteryAed Battery Exchange, LLC · 2012

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12012: 22013: 12014: 1
2008high 2 (2012) · low 0 (2010)2026

Most influential descendants

Showing 5 of 6 · See all
  • K081259Ddu-2300 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2009 · cites it directly3descendants
  • K131525Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2014 · 2 generations on0descendants
  • K113787Ddu-120 Fully Automatic External Defibrillator and AccessoriesDefibtech, LLC · 2013 · cites it directly0descendants
  • K121853Ddu-2400/2450 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2012 · 2 generations on0descendants
  • K120350Extended Life BatteryAed Battery Exchange, LLC · 2012 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K955628Fore Runner External Defibrillator/Defibrillator PadsHeartstream, Inc.1996—
0 (this device)K013896Sentry Semiautomatic External Defibrillator; External Defibrillation Pads…Defibtech, LLC2002—
+1K081259Ddu-2300 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC2009—
+2K131525Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC2014—
+1K113787Ddu-120 Fully Automatic External Defibrillator and AccessoriesDefibtech, LLC2013—
+2K121853Ddu-2400/2450 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC2012—
+2K120350Extended Life BatteryAed Battery Exchange, LLC2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201220
201310
201410
FIG. 1 — Lineage of K013896, 1996–2014Source: 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? (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
*K955628Fore Runner External Defibrillator/Defibrillator Pads
Summary page 1
…Manufacturer 51O(k) Number ForeRunner Heartstream, Inc. K955628 KDP-60 Katecho, Inc. K981737 Device Description The Sentry i…
Heartstream, Inc.1996—
*K981737K-Defib/Pace Adult Electrode Model Number KDP-60
Summary page 1
…Heartstream, Inc. K955628 KDP-60 Katecho, Inc. K981737 Device Description The Sentry is a semiautomatic external defibrillator (AED) designed to be portable and battery powered. It h…
Katecho, Inc.1998—

Also cleared against K955628: 6 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K081259Ddu-2300 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC20093
K113787Ddu-120 Fully Automatic External Defibrillator and AccessoriesDefibtech, LLC20130
K062970I-PADCu Medical Systems, Inc.20080

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 1, 2011Not classifiedZ-2064-2011Software design (manufacturing process)Software with version 2.004 software or earlier may cause an affected AED to cancel shock during the charging process
Aug 27, 2010Not classifiedZ-0077-2011Mixed-up of materials/componentsData cards may include an incorrect format which may cause the AED to not function correctly.
May 21, 2010Not classifiedZ-1781-2010Device DesignThe AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy
May 21, 2010Not classifiedZ-1782-2010Device DesignThe AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy
Feb 17, 2007Not classifiedZ-0580-2007Software designDevice Malfunction-The self-test software may allow a self-test to clear a previously detected low battery condition. If this occurs, the operator may be unaware of the low battery and the device may be "unable" to deliver a…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K081259 (Defibtech, LLC, 2009) has gone furthest, with 3 descendants of its own.
  • 6 other devices also cite its predicate K955628.

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 Sentry AED is indicated for use on victims of sudden cardiac arrest (“SCA”)

when the patient is:

- Unconscious and unresponsive

- Not breathing

- At least eight years old

The Sentry AED must be used by or on the order of a physician.

Indications for use as stated in the FDA summary.

Also cleared against K955628

6 other devices cite the same predicate.

  • K120350Extended Life BatteryAed Battery Exchange, LLC · 2012
  • K091548Amco Replacement Battery for Philips Medical Models BT1 and M5070AAmco International Manufacturing & Design, Inc. · 2009
  • K041883Skintact Multifunction Electrodes, Model DF 21Leonhard Lang GmbH · 2004
  • K991910Lifepak 12 BiphasicPhysio-Control Corp. · 19993 recalls
  • K983393Lifepak 500 BiphasicPhysio-Control Corp. · 19991 recall
  • K982264Firstsave Biphasic Models 9200 and 9210Survivalink Corp. · 1999

More from Defibtech, LLC

27 FDA decisions under this applicant name. See the company

  • P160032/S017Lifeline VIEW 2, Lifeline VIEW 2 AUTO and Lifeline ECG 2 AEDDefibtech, LLC · 2026
  • P160032/S014Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR…Defibtech, LLC · 2026
  • P160032/S016Defibtech Automated External Defibrillator (AED) SystemsDefibtech, LLC · 2026
  • P160032/S015Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO…Defibtech, LLC · 2026
  • P160032/S013Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO…Defibtech, LLC · 2025

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/K013896 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013896: Sentry Semiautomatic External Defibrillator; External Defibrillation Pads (Electrodes) DDP-100; Battery Pack 1200MAH; BA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013896

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026