Lifepak 12

• • Terminated Z-0495-05 FDA Unclassified (pre-2012) ·initiated 15 Jan 2005

  The LIFEPAK 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so.

510(k) Number

K040775 ↗

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 System

  Class III

  FDA 510(k) K010918 Active Cleared 23 Aug 2001

• LifePak 600 Automated External Defibrillator

  Class III

  FDA 510(k) K011144 Active Cleared 3 Dec 2001

• LifePak 500 Automated External Defibrillator

  Class III

  FDA 510(k) K012428 Active Cleared 28 Sep 2001

• Lifepak 12DEFIBERLLATOR/Monitor Series

  Class III

  FDA 510(k) K002445 Active Cleared 31 Jan 2001

• Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker

  Class II

  FDA 510(k) K012274 Active Cleared 5 Feb 2002

• LifePak 12, 20, 500, CR Plus

  Class III

  FDA 510(k) K033275 Active Cleared 6 Nov 2003

See all devices from Medtronic Physio-Control Corp. →

• What is the primary purpose of the LifePak 12 in emergency medical scenarios?

  The LifePak 12 is an Automated External Defibrillator (Non-Wearable) designed to deliver electrical shocks to restore a normal heart rhythm in patients experiencing sudden cardiac arrest. It provides voice prompts, real-time heart rhythm analysis, and biphasic defibrillation to improve resuscitation outcomes in prehospital and emergency settings.

• Is the LifePak 12 intended for repeated use, or is it meant to be used only once?

  The LifePak 12 is explicitly designed for single-use in emergency scenarios. It is not reusable, so each unit should be used once and then discarded.

• How is the LifePak 12 supplied, and what should buyers expect in the packaging?

  The LifePak 12 is supplied as a portable, non-reusable unit ready for immediate use in emergency situations. Since it is single-use, the packaging ensures functionality and sterility where applicable, though the device itself is not described as sterile in the data provided.

• What regulatory pathway was followed for the LifePak 12, and what classification does it hold?

  The LifePak 12 was authorized through an FDA 510(k) clearance (K040775) and is classified as a Class III medical device under regulation number 870.5310. This classification applies to devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present potential, unreasonable risk of illness or injury.

• Does the LifePak 12 require special handling or storage conditions?

  While specific storage conditions are not detailed in the provided data, the manufacturer recommends following guidelines to maintain functionality. Since it is a single-use device, proper storage ensures readiness for emergency use, though no explicit sterility or environmental requirements are mentioned beyond general handling precautions.