DDU-120 Fully Automatic External Defibrillator and Accessories

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K113787 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• RMU-2000 Automated Chest Compression System Open recall

  Class II

  FDA 510(k) K211289 Active Cleared 9 Nov 2021

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

  Class III

  FDA 510(k) K013896 Active Cleared 19 Jun 2002

• Ddu-2300 Semiautomatic External Defibrillator and Accessories

  Class III

  FDA 510(k) K081259 Active Cleared 15 Jun 2009

• Semiautomatic External Defibrillator and Accessories

  Class III

  FDA 510(k) K131525 Active Cleared 24 Apr 2014

• Defibtech Electrode Adapter, Model DAC-300 Series

  Class III

  FDA 510(k) K033144 Active Cleared 13 Nov 2003

• Defibtech AED with Attenuated Defibrillation/Monitoring Pads, Models DDU-100 with DDP-200P

  Class III

  FDA 510(k) K033896 Active Cleared 16 Jun 2004

See all devices from Defibtech, LLC →

• What types of environments is the DDU-120 designed for and how does it differ from wearable defibrillators?

  The DDU-120 is specifically designed for non-MRI environments and is intended for use in pre-hospital, emergency medical, and clinical settings where sudden cardiac arrest may occur. Unlike wearable defibrillators, which are often portable and designed for continuous monitoring and shock delivery over extended periods, the DDU-120 is a non-wearable automated external defibrillator (AED). It is meant for immediate, one-time use in emergencies, delivering biphasic waveforms and voice-guided resuscitation steps to restore normal heart rhythm.

• Are the electrodes for the DDU-120 single-use or reusable, and how should they be stored?

  The DDU-120 is supplied with single-use electrodes and adhesive pads, which means each pair is intended for one-time use only. While the device itself is reusable, the electrodes must be stored according to the manufacturer’s instructions to ensure proper functionality and sterility. Unlike the main unit, they do not require special storage conditions, but adherence to Defibtech’s guidelines is critical for optimal performance.

• What regulatory pathway was followed for FDA clearance of the DDU-120, and what classification does it hold?

  The DDU-120 received FDA 510(k) clearance under classification III (K113787), which is the highest risk classification for medical devices. This pathway was pursued through a traditional 510(k) review, with the device deemed substantially equivalent to predicate devices. The clearance falls under 21 CFR 870.5310, which governs automated external defibrillators, and was reviewed by the Cardiovascular (CV) Advisory Committee.

• How does the DDU-120 guide rescuers during use, and what kind of feedback does it provide?

  The DDU-120 is fully automatic, meaning it analyzes heart rhythms and determines whether defibrillation is needed without requiring manual intervention for shock delivery. It provides voice prompts to guide rescuers through each step of the resuscitation process, including CPR instructions and when to apply the electrodes. This hands-free operation ensures clarity and reduces potential errors during critical moments.