Cleared Traditional

LIFEPAK 15 monitor/defibrillator

K142430 · Physio-Control, Inc. · Cardiovascular

Dec 2014

Decision

112d

Days

Class 3

Risk

About This 510(k) Submission

K142430 is an FDA 510(k) clearance for the LIFEPAK 15 monitor/defibrillator, a Automated External Defibrillators (non-wearable) (Class III — Premarket Approval, product code MKJ), submitted by Physio-Control, Inc. (Redmond, US). The FDA issued a Cleared decision on December 19, 2014, 112 days after receiving the submission on August 29, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K142430 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 29, 2014
Decision Date	December 19, 2014
Days to Decision	112 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MKJ — Automated External Defibrillators (non-wearable)
Device Class	Class III — Premarket Approval
CFR Regulation	21 CFR 870.5310
Definition	This Device Is A Non-wearable Prescription Use Only Aed. These Are Devices That Include Automated External Defibrillation. Automated External Defibrillators Use External Pad-type Electrodes To Sense, Detect, Classify And Treat (with An Electrical Shock) Ventricular Fibrillation. These Devices Are Intended To Be Used On Suspected Victims Of Sudden Cardiac Arrest. A Person In Cardiac Arrest Is Unresponsive And Is Not Breathing Normally. The Device Can Be Sold With Prescription Only.