510(k) · Cleared
ClearedDdu-2300 Semiautomatic External Defibrillator and Accessories
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 15, 2009 as substantially equivalent to K013896 (Defibtech, LLC, 2002) and 1 other predicate after a 409-day review. Its family tree reaches back 2 generations to 1996. 3 later devices descend from it.
- Decided
- Jun 15, 2009
- Review
- 409 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K955628 (1996). 5 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK955628 Fore Runner External Defibrillator/Defibrillator PadsHeartstream, Inc. · 1996
- 1 generation backK013896 Sentry Semiautomatic External Defibrillator; External Defibrillation…Defibtech, LLC · 2002 · Recalled
- This deviceK081259 Ddu-2300 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2009
- Descendant · cites it directly · 0 of its ownK131525 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2014
- Descendant · cites it directly · 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 3 of 3 · See all- K131525Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2014 · cites it directly0descendants
- K121853Ddu-2400/2450 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2012 · cites it directly0descendants
- 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 |
|---|---|---|---|---|---|
| −2 | K955628 | Fore Runner External Defibrillator/Defibrillator Pads | Heartstream, Inc. | 1996 | — |
| −1 | K013896 | Sentry Semiautomatic External Defibrillator; External Defibrillation Pads… | Defibtech, LLC | 2002 | 5 |
| 0 (this device) | K081259 | Ddu-2300 Semiautomatic External Defibrillator and Accessories | Defibtech, LLC | 2009 | — |
| +1 | K131525 | Semiautomatic External Defibrillator and Accessories | Defibtech, LLC | 2014 | — |
| +1 | K121853 | Ddu-2400/2450 Semiautomatic External Defibrillator and Accessories | Defibtech, LLC | 2012 | — |
| +1 | K120350 | Extended Life Battery | Aed Battery Exchange, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013896 | Sentry Semiautomatic External Defibrillator; External Defibrillation Pads (Electrodes)…Summary page 1…lowing Proprietary Names: Proprietary Name Manufacturer 510(k) Number Sentry Semiautomatic External Defibtech, LLC K013896 Defibrillator, DDP- 100 Defibrillation Pads Defibtech AED with Attenuated Defibtech, LLC K033896' Defibrillat… | 2002 |
| * | K033896 | Defibtech Aed with Attenuated Defibrillation/Monitoring Pads, Models Ddu-100 with DDP-200PSummary page 1…automatic External Defibtech, LLC K013896 Defibrillator, DDP- 100 Defibrillation Pads Defibtech AED with Attenuated Defibtech, LLC K033896' Defibrillation/Monitoring Pads Defibtech, LLC- Page I of 3… | 2004 |
What descends from it? (3)
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)
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 13 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K131525 (Defibtech, LLC, 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K013896.
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. 2009, this device’s year, is highlighted.
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 DDU-2300 Semiautomatic External Defibrillator (AED) is indicated for use on victims of sudden cardiac arrest (SCA) who are:
* Unconscious and unresponsive
* Not breathing
For patients under 8 years old, or less than 55 pounds (25 kg), use child/infant electrode pads. Do not delay therapy to determine exact age or weight.
The DDU-2300 AED must be used by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081259 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081259: Ddu-2300 Semiautomatic External Defibrillator and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081259
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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