510(k) · Cleared
Recalled · 2011Defibtech Aed with Attenuated Defibrillation/Monitoring Pads, Models Ddu-100 with DDP-200P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Defibtech, LLC · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Jun 16, 2004 as substantially equivalent to K003819 (Agilent Technologies, Inc., 2001) after a 183-day review. Its family tree reaches back 1 generation to 2001. 5 later devices descend from it. It has been recalled once.
- Decided
- Jun 16, 2004
- Review
- 183 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003819 (2001). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK003819 Heartstream Attenuated Defibrillation Pads, Model M3870AAgilent Technologies, Inc. · 2001 · Recalled
- This deviceK033896 Defibtech Aed with Attenuated Defibrillation/Monitoring Pads, Models…Defibtech, LLC · 2004
- Descendant · cites it directly · 3 of its ownK081259 Ddu-2300 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2009
- Descendant · 2 generations on · 0 of its ownK131525 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2014
- Descendant · cites it directly · 0 of its ownK113787 Ddu-120 Fully Automatic External Defibrillator and AccessoriesDefibtech, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK121853 Ddu-2400/2450 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2012
- Descendant · cites it directly · 0 of its ownK120350 Extended Life BatteryAed Battery Exchange, LLC · 2012
Most influential descendants
Showing 5 of 5 · 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 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003819 | Heartstream Attenuated Defibrillation Pads, Model M3870A | Agilent Technologies, Inc. | 2001 | 4 |
| 0 (this device) | K033896 | Defibtech Aed with Attenuated Defibrillation/Monitoring Pads, Models Ddu-100… | Defibtech, LLC | 2004 | — |
| +1 | K081259 | Ddu-2300 Semiautomatic External Defibrillator and Accessories | Defibtech, LLC | 2009 | — |
| +2 | K131525 | Semiautomatic External Defibrillator and Accessories | Defibtech, LLC | 2014 | — |
| +1 | K113787 | Ddu-120 Fully Automatic External Defibrillator and Accessories | Defibtech, LLC | 2013 | — |
| +2 | K121853 | Ddu-2400/2450 Semiautomatic External Defibrillator and Accessories | Defibtech, LLC | 2012 | — |
| +1 | K120350 | Extended Life Battery | Aed Battery Exchange, LLC | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K003819 | Heartstream Attenuated Defibrillation Pads, Model M3870ASummary page 1…Manufacturer 510(k) Number Heartstream Attenuated Agilent Technologies, Inc. K003819 Defibrillation Pads Device Description Defibtech Attenuated Defibrillation/Monitoring Pads are intended for use only with Defibt… | 2001 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 1, 2011 | Not classified | Z-2064-2011 | Software design (manufacturing process) | Software with version 2.004 software or earlier may cause an affected AED to cancel shock during the charging process |
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 Attenuated Defibrillation/Monitoring Pads are to be used with Defibtech Series AEDs on victims of sudden cardiac arrest ("SCA") when the patient is:
-Unconscious and unresponsive
-Not breathing
- Less than eight years old
Defibtech Attenuated Defibrillation/Monitoring Pads must be used by or on the order of a physician.
Do not delay therapy to determine exact age or weight.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033896 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033896: Defibtech Aed with Attenuated Defibrillation/Monitoring Pads, Models Ddu-100 with DDP-200P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033896
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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