Defibtech Electrode Adapter, Model DAC-300 Series

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K033144 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• 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

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  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 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 Defibtech Electrode Adapter, Model DAC-300 Series, and how does it function in emergency cardiac care settings?

  The Defibtech Electrode Adapter, Model DAC-300 Series, serves as a reusable intermediary between Defibtech electrodes and automated or manual external defibrillators. Its role is to ensure proper electrical signal transmission for monitoring, pacing, and defibrillation, enabling compatibility between different electrode types and defibrillator connectors. This adapter is specifically designed for emergency cardiac care, allowing it to be used either as a standalone device or pre-attached to electrode packages.

• Is the Defibtech Electrode Adapter, Model DAC-300 Series, intended for single-use or reusable applications, and how should it be handled?

  The Defibtech Electrode Adapter, Model DAC-300 Series, is explicitly designed as a reusable accessory. Since it is meant for repeated use, proper cleaning and maintenance protocols must be followed to ensure reliability and safety in emergency cardiac care settings. The adapter operates within a temperature range of 0–50°C (32–122°F), which also supports its reuse in various environments.

• What regulatory pathway was followed for the FDA clearance of the Defibtech Electrode Adapter, Model DAC-300 Series, and which advisory committee was involved?

  The Defibtech Electrode Adapter, Model DAC-300 Series, received FDA clearance through a traditional 510(k) pathway, specifically classified as substantially equivalent (SESE) under decision code SESE. The device was reviewed by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a Class III medical device under FDA regulation 870.5310. The clearance number assigned is K033144.

• Which external defibrillators are compatible with the Defibtech Electrode Adapter, Model DAC-300 Series?

  The Defibtech Electrode Adapter, Model DAC-300 Series, is designed to be compatible with a wide range of automated external defibrillators (non-wearable), as indicated by the associated FDA registration numbers (e.g., 3026976873, 1218058, etc.). These registration numbers correspond to various defibrillator models, ensuring broad interoperability with compatible Defibtech electrodes and external defibrillators.