# K081259: Ddu-2300 Semiautomatic External Defibrillator and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Defibtech, LLC
- Decided: Jun 15, 2009 after 409 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: 2 generations back to K955628 (1996). 5 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013896: Sentry Semiautomatic External Defibrillator; External Defibrillation Pads (Electrodes) DDP-100; Battery Pack 1200MAH; BA, Defibtech, LLC (2002) Summary page 1.
- K033896: Defibtech Aed with Attenuated Defibrillation/Monitoring Pads, Models Ddu-100 with DDP-200P, Defibtech, LLC (2004) Summary page 1.

## Most influential descendants
- K131525: Semiautomatic External Defibrillator and Accessories (2014), 0 descendants of its own
- K121853: Ddu-2400/2450 Semiautomatic External Defibrillator and Accessories (2012), 0 descendants of its own
- K120350: Extended Life Battery (2012), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K081259
Methodology: https://510kreport.com/methodology