Cleared Traditional

CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel

K150198 · Bio-Detek, Inc. · Cardiovascular

May 2015

Decision

93d

Days

Class 3

Risk

About This 510(k) Submission

K150198 is an FDA 510(k) clearance for the CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel, a Automated External Defibrillators (non-wearable) (Class III — Premarket Approval, product code MKJ), submitted by Bio-Detek, Inc. (Pawtucket, US). The FDA issued a Cleared decision on May 2, 2015, 93 days after receiving the submission on January 29, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K150198 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 29, 2015
Decision Date	May 02, 2015
Days to Decision	93 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.