LifePak 12 Defibrillator/Monitor

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

510(k) Number

K041459 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• LifePak 12 Defibrillator/Monitor

  Class III

  FDA 510(k) K063510 Active Cleared 26 Jan 2007

• Lifenet Exchange System

  Class II

  FDA 510(k) K052854 Active Cleared 20 Jan 2006

• LifePak 1000

  Class III

  FDA 510(k) K042404 Active Cleared 22 Dec 2005

• Lifepak 20 Defibrillator/ Monitor

  Class III

  FDA 510(k) K063119 Active Cleared 22 Dec 2006

• LifePak 500 Automated External Defibrillator

  Class III

  FDA 510(k) K052057 Active Cleared 17 Feb 2006

• What types of clinical settings is the LifePak 12 Defibrillator/Monitor approved for use in, and how does it guide rescuers during resuscitation?

  The LifePak 12 is approved for use in prehospital, hospital, and clinical settings where life-threatening arrhythmias like ventricular fibrillation or pulseless ventricular tachycardia may occur. It combines real-time ECG monitoring with voice prompts to guide rescuers through resuscitation protocols, ensuring precise timing and delivery of synchronized cardioversion or defibrillation shocks to restore normal heart rhythm.

• Is the LifePak 12 Defibrillator/Monitor a single-use device, or can it be reused after cleaning? Why?

  The LifePak 12 is a reusable medical instrument, not a single-use device. Since it is not classified as sterile, it follows standard pre-use cleaning and disinfection protocols to maintain functionality and safety for repeated use in clinical environments.

• What safety considerations should be taken into account when storing or using the LifePak 12 near MRI equipment?

  The LifePak 12 is classified as a non-MRI conditional device, meaning it can be used in areas with MRI systems but must follow manufacturer guidelines to ensure safety. This typically involves maintaining appropriate distances from MRI machines and adhering to operational restrictions outlined in the device’s instructions to avoid interference or damage.

• How is the regulatory pathway for the LifePak 12 Defibrillator/Monitor structured, and what does this mean for its use?

  The LifePak 12 falls under FDA Class III regulatory classification and was cleared via a 510(k) pathway (K041459) with a special decision type, indicating it is substantially equivalent to a predicate device. This clearance confirms its compliance with FDA standards for safety and effectiveness, allowing it to be legally marketed and used in the U.S. for its intended purpose in prehospital, hospital, and clinical settings.