MKJ · Class III · 21 CFR 870.5310

FDA Product Code MKJ: Automated External Defibrillators (non-wearable)

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.

Leading manufacturers include Zoll Medical Corp, Zoll Medical Corporation, World Wide Headquarters and ZOLL Medical Corporation.

228
Total
228
Cleared
156d
Avg days
1985
Since

FDA 510(k) Cleared Automated External Defibrillators (non-wearable) Devices (Product Code MKJ)

228 devices
1–24 of 228
Cleared May 04, 2015
Powerheart G5 AED
K143714
Cardiac Science Corporation
Cardiovascular · 126d
Cleared May 02, 2015
OneStep Pediatric CPR Multi-Function Electrode
K150055
Bio-Detek, Inc.
Cardiovascular · 110d
Cleared May 02, 2015
CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel
K150198
Bio-Detek, Inc.
Cardiovascular · 93d
Cleared Mar 27, 2015
samaritan PAD 450P
K142709
Heartsine Technologies, Inc.
Cardiovascular · 186d
Cleared Jan 23, 2015
HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING
K133659
Philips Medical Systems
Cardiovascular · 422d
Cleared Jan 16, 2015
ZOLL E SERIES
K133239
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular · 452d
Cleared Dec 19, 2014
LIFEPAK 15 monitor/defibrillator
K142430
Physio-Control, Inc.
Cardiovascular · 112d
Cleared Dec 08, 2014
BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500
K141795
R & D Batteries, Inc.
Cardiovascular · 158d
Cleared Dec 03, 2014
ZOLL X Series
K142915
ZOLL Medical Corporation
Cardiovascular · 57d
Cleared Dec 02, 2014
Skintact, various other tradenames
K142803
Leonhard Lang GmbH
Cardiovascular · 64d
Cleared Nov 25, 2014
ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY
K141231
Zeller Power Products (Battery Beast, LLC)
Cardiovascular · 196d
Cleared Nov 19, 2014
ZOLL X SERIES
K141774
ZOLL Medical Corporation
Cardiovascular · 140d
Cleared Oct 10, 2014
ONESTEP CPR II MULTI-FUNCTION ELECTRODE
K133441
Bio-Detek, Inc.
Cardiovascular · 332d
Cleared Aug 01, 2014
ZOLL X SERIES
K133484
Zoll Medical Corp
Cardiovascular · 261d
Cleared May 22, 2014
ZOLL X SERIES
K133269
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular · 210d
Cleared Apr 24, 2014
SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
K131525
Defibtech, LLC
Cardiovascular · 331d
Cleared Feb 12, 2014
POWERHEART G5 AED
K122758
Cardiac Science Corporation
Cardiovascular · 520d
Cleared Dec 06, 2013
HEART SYNC
K131550
Heart Sync, Inc.
Cardiovascular · 191d
Cleared Oct 18, 2013
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
K130684
Philips Medical Systems
Cardiovascular · 219d
Cleared Sep 16, 2013
HEART SYNC
K131494
Heart Sync, Inc.
Cardiovascular · 116d
Cleared Aug 21, 2013
LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR
K130454
Physio-Control, Inc.
Cardiovascular · 180d
Cleared Jul 11, 2013
HEARTSINE SAMARITAN PAD 350P
K123881
Heartsine Technologies, Inc.
Cardiovascular · 206d
Cleared Mar 12, 2013
HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST
K130153
Philips Medical Systems
Cardiovascular · 49d
Cleared Jan 04, 2013
DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
K113787
Defibtech, LLC
Cardiovascular · 379d

About Product Code MKJ - Regulatory Context