Semiautomatic External Defibrillator and Accessories

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K131525 ↗

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

• DDU-120 Fully Automatic External Defibrillator and Accessories

  Class III

  FDA 510(k) K113787 Active Cleared 4 Jan 2013

• 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 →

• How does the DDU-1000 differ from fully automatic external defibrillators in terms of operation and user involvement?

  The DDU-1000 is a semiautomatic external defibrillator, meaning it analyzes the patient’s heart rhythm and advises when a shock is advised. However, unlike fully automatic devices, it requires manual activation by the operator pressing the shock button to deliver therapy, ensuring the user remains engaged in the decision-making process.

• Are the electrodes and pads for the DDU-1000 reusable or single-use, and how should they be stored?

  The DDU-1000 system is designed with single-use electrodes and pads, while the defibrillator itself is reusable. Proper storage requires keeping the device in a dry, temperature-controlled environment to maintain its functionality and reliability.

• Can the DDU-1000 be used in an MRI environment, and if not, what precautions should be taken?

  The DDU-1000 is explicitly stated as not MRI-safe, so it should never be used in or near an MRI environment. Precautions include removing the device from the area and ensuring no metallic components are exposed to the MRI field, as this could pose a risk to both the patient and the equipment.

• What regulatory pathway was followed for the FDA clearance of the DDU-1000, and what is its classification?

  The DDU-1000 holds an FDA 510(k) clearance under product code MKJ, classified as substantially equivalent to predicate Automated External Defibrillators (Non-Wearable). The clearance was granted through a traditional review process by the Cardiovascular (CV) Advisory Committee, with a decision date of April 24, 2014.