# K131525: Semiautomatic External Defibrillator and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Defibtech, LLC
- Decided: Apr 24, 2014 after 331 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K955628 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081259: Ddu-2300 Semiautomatic External Defibrillator and Accessories, Defibtech, LLC (2009) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K131525
Methodology: https://510kreport.com/methodology