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 Philips Medical Systems, Physio-Control Corp. and Hewlett-Packard Co..

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 Jan 23, 2015
HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING
K133659
Philips Medical Systems
Cardiovascular · 422d
Cleared Dec 08, 2014
BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500
K141795
R & D Batteries, Inc.
Cardiovascular · 158d
Cleared Oct 18, 2013
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
K130684
Philips Medical Systems
Cardiovascular · 219d
Cleared Mar 12, 2013
HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST
K130153
Philips Medical Systems
Cardiovascular · 49d
Cleared Feb 16, 2012
PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES
K110825
Philips Medical Systems
Cardiovascular · 330d
Cleared Oct 28, 2011
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
K111693
Philips Medical Systems
Cardiovascular · 134d
Cleared Feb 26, 2008
PHILIPS HEARTSTART SMARTPADS III
K072812
Philips Medical Systems
Cardiovascular · 148d
Cleared Jan 11, 2007
HEARTSTART MRX, MODELS M3535A OR M3536A
K063375
Philips Medical Systems
Cardiovascular · 64d
Cleared Nov 22, 2006
HEARTSTART MRX MONITOR/DEFIBRILLATOR
K062233
Philips Medical Systems North America, Inc.
Cardiovascular · 112d
Cleared Aug 11, 2006
HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS
K061707
Philips Medical Systems
Cardiovascular · 56d
Cleared Oct 05, 2005
PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A
K051632
Philips Medical Systems
Cardiovascular · 107d
Cleared Sep 08, 2005
HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A
K051134
Philips Medical Systems
Cardiovascular · 128d
Cleared Feb 25, 2005
PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304
K050004
Philips Medical Systems
Cardiovascular · 54d
Cleared Sep 14, 2004
PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20
K040479
Welch Allyn, Inc.
Cardiovascular · 202d
Cleared May 04, 2004
HEARTSTART MRX, MODEL M3535A
K040404
Philips Medical Systems, Inc.
Cardiovascular · 77d
Cleared Aug 27, 2003
HEARTSTART MRX, MODEL M3535A
K031187
Philips Medical Systems
Cardiovascular · 134d
Cleared Nov 08, 2002
PHILIPS M5066A AND M5068A
K020715
Philips Medical Systems
Cardiovascular · 248d
Cleared Jul 03, 2002
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A
K021453
Philips Medical Systems
Cardiovascular · 58d
Cleared Jan 17, 2002
HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A
K014157
Philips Medical Systems
Cardiovascular · 29d
Cleared Jan 14, 2002
HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A
K013425
Philips Medical Systems
Cardiovascular · 90d
Cleared Feb 05, 2001
PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602
K002280
Medical Devices, Inc.
Cardiovascular · 194d
Cleared May 18, 2000
HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE
K992543
Hewlett-Packard Co.
Cardiovascular · 293d
Cleared Dec 01, 1999
HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A
K992977
Hewlett-Packard Co.
Cardiovascular · 89d
Cleared Sep 03, 1999
LIFEPAK 12 BIPHASIC
K991910
Physio-Control Corp.
Cardiovascular · 88d

About Product Code MKJ - Regulatory Context