Cleared Traditional

REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351

K052465 · Heartsine Technologies, Inc. · Cardiovascular

Dec 2006

Decision

460d

Days

Class 3

Risk

About This 510(k) Submission

K052465 is an FDA 510(k) clearance for the REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351, a Automated External Defibrillators (non-wearable) (Class III — Premarket Approval, product code MKJ), submitted by Heartsine Technologies, Inc. (Newtown, US). The FDA issued a Cleared decision on December 12, 2006, 460 days after receiving the submission on September 8, 2005. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K052465 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 08, 2005
Decision Date	December 12, 2006
Days to Decision	460 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.