FDA Product Code
FDA Product Code MKJ — Clearance Directory
- Device Class
- Class III
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5310
510(k) Clearances — 228 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K143714 | Powerheart G5 AED | Cardiac Science Corporation | 2015-05-04 | Traditional | PDF ↗ |
| K150055 | OneStep Pediatric CPR Multi-Function Electrode | Bio-Detek, Inc. | 2015-05-02 | Traditional | PDF ↗ |
| K150198 | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel | Bio-Detek, Inc. | 2015-05-02 | Traditional | PDF ↗ |
| K142709 | samaritan PAD 450P | Heartsine Technologies, Inc. | 2015-03-27 | Traditional | PDF ↗ |
| K133659 | HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING | Philips Medical Systems | 2015-01-23 | Traditional | PDF ↗ |
| K133239 | ZOLL E SERIES | Zoll Medical Corporation, World Wide Headquarters | 2015-01-16 | Traditional | PDF ↗ |
| K142430 | LIFEPAK 15 monitor/defibrillator | Physio-Control, Inc. | 2014-12-19 | Traditional | PDF ↗ |
| K141795 | BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 | R & D Batteries, Inc. | 2014-12-08 | Traditional | PDF ↗ |
| K142915 | ZOLL X Series | ZOLL Medical Corporation | 2014-12-03 | Traditional | PDF ↗ |
| K142803 | Skintact, various other tradenames | Leonhard Lang GmbH | 2014-12-02 | Traditional | PDF ↗ |
| K141231 | ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY | Zeller Power Products (Battery Beast, LLC) | 2014-11-25 | Traditional | PDF ↗ |
| K141774 | ZOLL X SERIES | ZOLL Medical Corporation | 2014-11-19 | Traditional | PDF ↗ |
| K133441 | ONESTEP CPR II MULTI-FUNCTION ELECTRODE | Bio-Detek, Inc. | 2014-10-10 | Traditional | PDF ↗ |
| K133484 | ZOLL X SERIES | Zoll Medical Corp | 2014-08-01 | Traditional | PDF ↗ |
| K133269 | ZOLL X SERIES | Zoll Medical Corporation, World Wide Headquarters | 2014-05-22 | Traditional | PDF ↗ |
| K131525 | SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES | Defibtech, LLC | 2014-04-24 | Traditional | PDF ↗ |
| K122758 | POWERHEART G5 AED | Cardiac Science Corporation | 2014-02-12 | Traditional | PDF ↗ |
| K131550 | HEART SYNC | Heart Sync, Inc. | 2013-12-06 | Traditional | PDF ↗ |
| K130684 | PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR | Philips Medical Systems | 2013-10-18 | Traditional | PDF ↗ |
| K131494 | HEART SYNC | Heart Sync, Inc. | 2013-09-16 | Traditional | PDF ↗ |
| K130454 | LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR | Physio-Control, Inc. | 2013-08-21 | Traditional | PDF ↗ |
| K123881 | HEARTSINE SAMARITAN PAD 350P | Heartsine Technologies, Inc. | 2013-07-11 | Traditional | PDF ↗ |
| K130153 | HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST | Philips Medical Systems | 2013-03-12 | Traditional | PDF ↗ |
| K113787 | DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES | Defibtech, LLC | 2013-01-04 | Traditional | PDF ↗ |
| K122839 | ZOLL SUREPOWER SINGLE BAY CHARGER | ZOLL Medical Corporation | 2012-12-13 | Special | PDF ↗ |
| K121853 | DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES | Defibtech, LLC | 2012-12-13 | Traditional | PDF ↗ |
| K120350 | EXTENDED LIFE BATTERY | Aed Battery Exchange, LLC | 2012-11-01 | Traditional | PDF ↗ |
| K120406 | ZOLL FULLY AUTOMATIC AED PLUS | Zoll Medical Corporation, World Wide Headquarters | 2012-10-26 | Traditional | PDF ↗ |
| K122600 | LIFEPAK 1000 DEFIBRILLATOR | Physio-Control, Inc. | 2012-10-11 | Traditional | PDF ↗ |
| K120907 | ZOLL R SERIES | Zoll Medical Corporation, World Wide Headquarters | 2012-09-25 | Traditional | PDF ↗ |
| K120536 | HEART SYNC PEDIATRIC PHYSIO AED PAD | Heart Sync, Inc. | 2012-08-06 | Traditional | PDF ↗ |
| K112761 | ZOLL PROPAQ MD | Zoll Medical Corporation, World Wide Headquarters | 2012-04-25 | Traditional | PDF ↗ |
| K112432 | ZOLL X SERIES | Zoll Medical Corporation, World Wide Headquarters | 2012-03-21 | Traditional | PDF ↗ |
| K110825 | PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES | Philips Medical Systems | 2012-02-16 | Traditional | PDF ↗ |
| K111693 | PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR | Philips Medical Systems | 2011-10-28 | Traditional | PDF ↗ |
| K111594 | ZOLL E SERIES | Zoll Medical Corporation, World Wide Headquarters | 2011-08-17 | Traditional | PDF ↗ |
| K102496 | POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS | Cardiac Science Corporation | 2011-06-09 | Special | PDF ↗ |
| K110978 | ONESTEP PEDIATRIC MFE'S | ZOLL Medical Corporation | 2011-05-13 | Abbreviated | PDF ↗ |
| K110742 | ONESTEP ADULT MULTI-FUNCTION ELECTRODE | ZOLL Medical Corporation | 2011-04-13 | Special | PDF ↗ |
| K110526 | ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE | ZOLL Medical Corporation | 2011-03-25 | Special | PDF ↗ |
| K103567 | LIFEPAK 15 MONITOR/DEFIBRILLATOR | Physio-Control, Inc. | 2011-03-22 | Traditional | PDF ↗ |
| K110361 | ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE | Zoll Medical Corporation, World Wide Headquarters | 2011-03-08 | Special | PDF ↗ |
| K110168 | ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE | Zoll Medical Corporation, World Wide Headquarters | 2011-02-17 | Special | PDF ↗ |
| K110154 | ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE | Zoll Medical Corporation, World Wide Headquarters | 2011-02-17 | Special | PDF ↗ |
| K103186 | SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES | Leonhard Lang GmbH | 2011-02-08 | Traditional | PDF ↗ |
| K102972 | LIFEPAK 12 | Physio-Control, Inc. | 2010-12-22 | Special | PDF ↗ |
| K100565 | DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325 | Bio-Detek, Inc. | 2010-11-16 | Traditional | PDF ↗ |
| K091561 | ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE | ZOLL Medical Corporation | 2010-09-23 | Traditional | PDF ↗ |
| K092391 | MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED | Concord Medical Products | 2010-04-01 | Traditional | PDF ↗ |
| K091265 | ZOLL E SERIES WITH CPRREADYCHARGE | Zoll Medical Corporation, World Wide Headquarters | 2009-12-23 | Traditional | PDF ↗ |
| K092598 | ZOLL E SERIES WITH SPCO/SPMET OPTION | Zoll Medical Corporation, World Wide Headquarters | 2009-12-03 | Traditional | PDF ↗ |
| K090989 | ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES | Zoll Medical Corp | 2009-09-23 | Traditional | PDF ↗ |
| K091943 | POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A | Cardiac Science Corporation | 2009-09-10 | Special | PDF ↗ |
| K091548 | AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A | Amco International Manufacturing & Design, Inc. | 2009-08-07 | Traditional | PDF ↗ |
| K081259 | DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES | Defibtech, LLC | 2009-06-15 | Traditional | PDF ↗ |
| K082937 | LIFEPAK 15 MONITOR/DEFIBRILLATOR | Physio-Control, Inc. | 2009-03-11 | Traditional | PDF ↗ |
| K081081 | ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING | Zoll Medical Corporation, World Wide Headquarters | 2009-03-09 | Traditional | PDF ↗ |
| K082090 | 9131 DEFIBRILLATION ELECTRODES | Cardiac Science Corporation | 2008-12-12 | Special | PDF ↗ |
| K081828 | ZOLL R SERIES BLS DEFIBRILLATOR | ZOLL Medical Corporation | 2008-12-09 | Traditional | PDF ↗ |
| K080903 | ZOLL E SERIES WITH INTIBATION ASSIST OPTION | ZOLL Medical Corporation | 2008-12-04 | Special | PDF ↗ |
| K082861 | AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561 | Amco International Manufacturing & Design, Inc. | 2008-11-25 | Traditional | PDF ↗ |
| K081371 | SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL | Leonhard Lang GmbH | 2008-09-24 | Traditional | PDF ↗ |
| K073089 | LIFEPAK 20E | Physio-Control, Inc. | 2008-07-29 | Traditional | PDF ↗ |
| K072923 | ZOLL E SERIES DEFIBRILLATOR | Zoll Medical Corporation, World Wide Headquarters | 2008-04-24 | Traditional | PDF ↗ |
| K080232 | ZOLL E SERIES 12SL, ANALYSIS OPTION | Zoll Medical Corporation, World Wide Headquarters | 2008-04-23 | Special | PDF ↗ |
| K073716 | LIFE+CEL OR LIFECEL BATTERY | Amco International Manufacturing & Design, Inc. | 2008-04-11 | Traditional | PDF ↗ |
| K080421 | HEART SYNC, MODELS C-100 AND T-100 | Heart Sync, LLC | 2008-02-29 | Traditional | PDF ↗ |
| K072812 | PHILIPS HEARTSTART SMARTPADS III | Philips Medical Systems | 2008-02-26 | Traditional | PDF ↗ |
| K072596 | LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500 | Amco International Manufacturing & Design, Inc. | 2008-01-24 | Traditional | PDF ↗ |
| K062970 | I-PAD | Cu Medical Systems, Inc. | 2008-01-22 | Traditional | PDF ↗ |
| K072430 | ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE | ZOLL Medical Corporation | 2007-11-06 | Traditional | PDF ↗ |
| K072233 | SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS | Leonhard Lang GmbH | 2007-10-05 | Special | PDF ↗ |
| K071025 | ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO | Zoll Medical Corporation, World Wide Headquarters | 2007-06-22 | Special | PDF ↗ |
| K070455 | ZOLL E SERIES WITH SEE-THRU CPR | Zoll Medical Corporation, World Wide Headquarters | 2007-04-26 | Special | PDF ↗ |
| K062537 | ZOLL M SERIES WITH REAL CPR HELP | ZOLL Medical Corporation | 2007-02-28 | Traditional | PDF ↗ |
| K063510 | LIFEPAK 12 DEFIBRILLATOR/MONITOR | Medtronic Emergency Response Systems, Inc. | 2007-01-26 | Special | PDF ↗ |
| K063375 | HEARTSTART MRX, MODELS M3535A OR M3536A | Philips Medical Systems | 2007-01-11 | Special | PDF ↗ |
| K063119 | LIFEPAK 20 DEFIBRILLATOR/ MONITOR | Medtronic Emergency Response Systems, Inc. | 2006-12-22 | Special | PDF ↗ |
| K062177 | ZOLL E SERIES WITH REAL CPR HELP | ZOLL Medical Corporation | 2006-12-13 | Traditional | PDF ↗ |
| K052465 | REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351 | Heartsine Technologies, Inc. | 2006-12-12 | Traditional | PDF ↗ |
| K062233 | HEARTSTART MRX MONITOR/DEFIBRILLATOR | Philips Medical Systems North America, Inc. | 2006-11-22 | Special | PDF ↗ |
| K060559 | ZOLL R SERIES DEFIBRILLATOR | ZOLL Medical Corporation | 2006-08-17 | Traditional | PDF ↗ |
| K061707 | HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS | Philips Medical Systems | 2006-08-11 | Abbreviated | PDF ↗ |
| K060934 | MODIFICATION TO POWERHEART ECD | Cardiac Science Corporation | 2006-05-15 | Special | PDF ↗ |
| K052057 | LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR | Medtronic Emergency Response Systems, Inc. | 2006-02-17 | Traditional | PDF ↗ |
| K052316 | POWERHEART ECD | Cardiac Science, Inc. | 2006-01-03 | Traditional | PDF ↗ |
| K042404 | LIFEPAK, MODEL 1000 | Medtronic Emergency Response Systems, Inc. | 2005-12-22 | Traditional | PDF ↗ |
| K052161 | POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A) | Cardiac Science, Inc. | 2005-10-21 | Special | PDF ↗ |
| K051632 | PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A | Philips Medical Systems | 2005-10-05 | Traditional | PDF ↗ |
| K051134 | HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A | Philips Medical Systems | 2005-09-08 | Traditional | PDF ↗ |
| K051475 | ZOLL M SERIES 12SL ANALYSIS OPTION | ZOLL Medical Corporation | 2005-06-24 | Special | PDF ↗ |
| K051076 | ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES | ZOLL Medical Corporation | 2005-05-13 | Special | PDF ↗ |
| K042007 | ZOLL E SERIES DEFIBRILLATOR | Zoll Medical Corp | 2005-04-07 | Traditional | PDF ↗ |
| K050004 | PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304 | Philips Medical Systems | 2005-02-25 | Special | PDF ↗ |
| K041892 | ZOLL AED PRO EXTERNAL DEFIBRILLATOR | ZOLL Medical Corporation | 2005-02-04 | Traditional | PDF ↗ |
| K042417 | ZOLL M SERIES ETC02 LOFLO OPTION | Zoll Medical Corp | 2004-10-05 | Special | PDF ↗ |
| K040479 | PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20 | Welch Allyn, Inc. | 2004-09-14 | Traditional | PDF ↗ |
| K041883 | SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 | Leonhard Lang GmbH | 2004-09-07 | Traditional | PDF ↗ |
| K042088 | SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301 | Heartsine Technologies, Inc. | 2004-09-02 | Traditional | PDF ↗ |
| K040637 | POWERHEART AED G3 PRO | Cardiac Science, Inc. | 2004-08-06 | Traditional | PDF ↗ |
Product code MKJ · Class III · Cardiovascular. Data: openFDA.