Ddu-2300 Semiautomatic External Defibrillator and Accessories

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K081259 ↗

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

• 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

• 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 is the primary purpose of the DDU-2300 Semi-Automatic External Defibrillator in emergency settings?

  The DDU-2300 is designed to deliver electrical shocks to restore a normal heart rhythm in patients experiencing sudden cardiac arrest. It analyzes heart rhythms and provides automated advice to operators, delivering shocks only after user confirmation. This makes it ideal for out-of-hospital use in public spaces, workplaces, or first-responder environments where cardiac arrest may occur unexpectedly.

• Is the DDU-2300 intended for single-use or reusable applications, and what does that mean for maintenance?

  The DDU-2300 is a reusable device but is intended for single-patient use per cycle before maintenance. This means it can be used repeatedly across different patients, but after each use, it requires calibration, battery checks, and periodic inspections as outlined by the manufacturer to ensure proper functionality and safety.

• Can this defibrillator be used in environments where MRI machines are present, and why?

  No, the DDU-2300 is not MRI-compatible, so it should not be used in environments where MRI safety is a concern. This is explicitly stated in the device’s specifications, as its design does not account for electromagnetic interference or safety protocols required near MRI equipment.

• What regulatory pathway was followed for FDA clearance of the DDU-2300, and what class does it belong to?

  The DDU-2300 received FDA clearance through a 510(k) submission, specifically under the Traditional clearance type, and was reviewed by the Cardiovascular (CV) Advisory Committee. It is classified as a Class III medical device under product code MKJ, indicating it addresses high-risk medical purposes requiring stringent regulatory oversight.

• How should the DDU-2300 be stored and handled to maintain its functionality?

  The DDU-2300 follows standard defibrillator storage and handling protocols, which include proper calibration, battery maintenance, and periodic inspections. The manufacturer provides guidelines for these procedures, ensuring the device remains reliable for emergency use. Regular upkeep is critical, especially since it is reusable and intended for repeated use across multiple patients.