510(k) · Cleared
ClearedSemiautomatic 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 Apr 24, 2014 as substantially equivalent to K081259 (Defibtech, LLC, 2009) after a 331-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Apr 24, 2014
- Review
- 331 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K955628 (1996). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK955628 Fore Runner External Defibrillator/Defibrillator PadsHeartstream, Inc. · 1996
- 2 generations backK013896 Sentry Semiautomatic External Defibrillator; External Defibrillation…Defibtech, LLC · 2002 · Recalled
- 1 generation backK081259 Ddu-2300 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2009
- This deviceK131525 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955628 | Fore Runner External Defibrillator/Defibrillator Pads | Heartstream, Inc. | 1996 | — |
| −2 | K013896 | Sentry Semiautomatic External Defibrillator; External Defibrillation Pads… | Defibtech, LLC | 2002 | 5 |
| −1 | K081259 | Ddu-2300 Semiautomatic External Defibrillator and Accessories | Defibtech, LLC | 2009 | — |
| 0 (this device) | K131525 | Semiautomatic External Defibrillator and Accessories | Defibtech, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K081259 | Ddu-2300 Semiautomatic External Defibrillator and AccessoriesSummary page 1…Proprietary Name: Proprietary Name Manufacturer 510(k) Number DDU-2300 Semiautomatic Defibtech, LLC K08 1259 External Defibrillator and Accessories Defibtech LLC Attachment 3… | 2009 |
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 18 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K081259.
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. 2014, 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-OOO Semiautomatic External Defibrillator (AED) isindicated 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 (25kg), use child/infant electrode pads. Do not
delay therapy to determine exact age or weight.
The ODU-lOOO0 AED must be used by or on the order of aphysician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131525: Semiautomatic External Defibrillator and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131525
Report an extraction error
Are you the manufacturer?
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