Aedefibrillator

• • Terminated Z-1223-2007 FDA Unclassified (pre-2012) ·initiated 23 Aug 2007

  Failure to deliver therapy: The Welch Allyn AED20 Defibrillators may display a "Defib Comm" error message on the device display during use which may result in failure of the device to analyze the patient's ECG and deliver the appropriate therapy.

• • Terminated Z-1106-06 FDA Unclassified (pre-2012) ·initiated 15 Jun 2006

  The Welch Allyn AED 20 Defibrillators may display a 'Defib Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy.

• • Terminated Z-0806-05 FDA Unclassified (pre-2012) ·initiated 28 Apr 2005

  The Welch Allyn AED 20 product may display a 'Defib Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropiate therapy.

510(k) Number

K002232 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Porta Pak 90

  Class II

  FDA 510(k) K840900 Active Cleared 11 Jun 1984

• Dpd Defibrillator

  Class II

  FDA 510(k) K952085 Active Cleared 5 Jun 1995

• Porta Pulse III #D320

  Class II

  FDA 510(k) K833751 Active Cleared 11 Jan 1984

• Portable Intensive Care Unit Modification

  Class III

  FDA 510(k) K983307 Active Cleared 20 Nov 1998

• Mrl Blood Pressure Monitor

  Class II

  FDA 510(k) K885191 Active Cleared 23 May 1989

• 450SLL Defibrillator

  Class II

  FDA 510(k) K874204 Active Cleared 28 Jan 1988

See all devices from Medical Research Laboratories, Inc. →

• Is the Aedefibrillator designed for single-use or can it be reused in multiple emergency situations?

  The Aedefibrillator is explicitly described as a reusable medical instrument, meaning it is built for repeated use in emergency settings. Since it is classified as a Class 3 Cardiovascular device under FDA 510(k) clearance, its design and maintenance protocols ensure durability and reliability for multiple deployments, provided it undergoes proper cleaning, inspection, and calibration as required by regulatory standards.

• What types of environments is the Aedefibrillator intended for, and how does its design accommodate non-medical users?

  The Aedefibrillator is designed for pre-hospital and emergency care environments, including settings where lay responders (non-medical personnel) may need to use it. Its automated functionality eliminates the need for direct user contact with the patient, simplifying operation for untrained individuals during sudden cardiac arrest scenarios. This makes it accessible for first responders, public spaces, and locations where medical professionals may not be immediately available.

• How is the Aedefibrillator regulated, and what does its FDA 510(k) clearance indicate about its safety and performance?

  The Aedefibrillator is regulated under the FDA 510(k) clearance pathway, specifically with clearance number K002232 and product code MKJ. This indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device, meeting the safety and performance requirements outlined in 21 CFR 870.5310 for cardiovascular defibrillators. The Traditional 510(k) pathway ensures compliance with rigorous review by the FDA’s Cardiovascular (CV) advisory committee.

• Are there different models or sizes available for the Aedefibrillator, and how might this affect its use in various settings?

  The provided data does not specify distinct models or sizes for the Aedefibrillator, but its classification as a non-wearable automated external defibrillator suggests it is designed for general emergency use. Since it is intended for pre-hospital and emergency care, its portability and universal design likely make it adaptable to various settings without requiring size-specific variations. For precise sizing or model-specific details, consulting the manufacturer’s technical documentation would be necessary.