# K013896: Sentry Semiautomatic External Defibrillator; External Defibrillation Pads (Electrodes) DDP-100; Battery Pack 1200MAH; BA

- Pathway: 510(k) (Traditional)
- Applicant: Defibtech, LLC
- Decided: Jun 19, 2002 after 208 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955628 (1996). 2 ancestors in all.
6 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)
- K955628: Fore Runner External Defibrillator/Defibrillator Pads, Heartstream, Inc. (1996) Summary page 1.
- K981737: K-Defib/Pace Adult Electrode Model Number KDP-60, Katecho, Inc. (1998) 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
- Aug 27, 2010 · Not classified · Z-0077-2011: Data cards may include an incorrect format which may cause the AED to not function correctly.
- May 21, 2010 · Not classified · Z-1781-2010: The AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy
- May 21, 2010 · Not classified · Z-1782-2010: The AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy
- Feb 17, 2007 · Not classified · Z-0580-2007: Device Malfunction-The self-test software may allow a self-test to clear a previously detected low battery condition. If this occurs, the operator may be unaware of the low battery and the device may 

## Indications for use
The Sentry AED is indicated for use on victims of sudden cardiac arrest (“SCA”) when the patient is: - Unconscious and unresponsive - Not breathing - At least eight years old The Sentry AED must be used by or on the order of a physician.

Source page: https://510kreport.com/device/K013896
Methodology: https://510kreport.com/methodology