Ddu-2400/2450 Semiautomatic External Defibrillator and Accessories

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K121853 ↗

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

• 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

See all devices from Defibtech, LLC →

• What types of settings can the DDU-2400/2450 be used in, and why is it considered reusable?

  The DDU-2400/2450 is designed for use in pre-hospital, emergency, and clinical settings where sudden cardiac arrest may occur. It is classified as a reusable medical device, meaning it is built to withstand repeated use and maintenance, ensuring reliability in critical situations where multiple patients may require defibrillation. This design aligns with the need for durable, long-term equipment in environments like ambulances, hospitals, and public access defibrillation programs.

• How does the DDU-2400/2450 determine whether a shock is needed, and who can operate it?

  The DDU-2400/2450 is a semi-automatic external defibrillator, meaning it analyzes the patient’s heart rhythm and advises whether a shock is required. It guides lay responders—such as first responders, bystanders, or untrained personnel—through the process, ensuring they can administer life-saving intervention promptly without needing advanced medical training. This feature is particularly valuable in emergency situations where quick action is critical.

• Are there any special storage or handling requirements for the DDU-2400/2450, and can it be used near MRI machines?

  The DDU-2400/2450 follows standard medical device storage and handling protocols, which typically include keeping it in a clean, dry environment away from extreme temperatures or direct sunlight. There are no specific MRI safety restrictions mentioned for this device, meaning it can generally be stored in areas where MRI machines are present without risk of interference. However, it should never be placed inside an MRI scanner or exposed to strong magnetic fields during operation.

• What regulatory pathway was followed for the FDA clearance of the DDU-2400/2450, and how does this affect its use?

  The DDU-2400/2450 received FDA clearance through a 510(k) submission, specifically classified under Traditional Review with a Substantially Equivalent (SESE) determination by the Cardiovascular (CV) Advisory Committee. This means the device was deemed equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for automated external defibrillators. Clinicians and buyers can rely on this clearance to confirm the device’s regulatory compliance for use in treating sudden cardiac arrest.