# K033896: Defibtech Aed with Attenuated Defibrillation/Monitoring Pads, Models Ddu-100 with DDP-200P

- Pathway: 510(k) (Traditional)
- Applicant: Defibtech, LLC
- Decided: Jun 16, 2004 after 183 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003819 (2001). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003819: Heartstream Attenuated Defibrillation Pads, Model M3870A, Agilent Technologies, Inc. (2001) Summary page 1.

## Most influential descendants
- K081259: Ddu-2300 Semiautomatic External Defibrillator and Accessories (2009), 3 descendants of its own
- K131525: Semiautomatic External Defibrillator and Accessories (2014), 0 descendants of its own
- K113787: Ddu-120 Fully Automatic External Defibrillator and Accessories (2013), 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

## Recalls of this device
- Apr 1, 2011 · Not classified · Z-2064-2011: Software with version 2.004 software or earlier may cause an affected AED to cancel shock during the charging process

## Indications for use
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.

Source page: https://510kreport.com/device/K033896
Methodology: https://510kreport.com/methodology