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 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K040438 | POWERHEART AED G3A | Cardiac Science, Inc. | 2004-07-01 | Traditional | PDF ↗ |
| K041459 | LIFEPAK 12 DEFIBRILLATOR/MONITOR | Medtronic Emergency Response Systems, Inc. | 2004-07-01 | Special | PDF ↗ |
| K033896 | DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P | Defibtech, LLC | 2004-06-16 | Traditional | PDF ↗ |
| K033642 | SMARTLANK WIRELESS, MODEL 001970 | Mrl, A Welch Allyn Company | 2004-05-25 | Traditional | PDF ↗ |
| K041067 | HEARTSINE SAMARITAN PAD | Heartsine Technologies, Inc. | 2004-05-25 | Special | PDF ↗ |
| K033474 | ZOLL AED PLUS | Zoll Medical Corp | 2004-05-21 | Traditional | PDF ↗ |
| K040404 | HEARTSTART MRX, MODEL M3535A | Philips Medical Systems, Inc. | 2004-05-04 | Traditional | PDF ↗ |
| K040775 | LIFEPAK 12 | Medtronic Physio-Control Corp. | 2004-04-23 | Special | PDF ↗ |
| K040256 | PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005 | Bio-Detek, Inc. | 2004-04-09 | Traditional | PDF ↗ |
| K040056 | BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90 | Bio-Detek, Inc. | 2004-04-09 | Traditional | PDF ↗ |
| K033771 | BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR | Bio-Detek, Inc. | 2004-02-27 | Traditional | PDF ↗ |
| K032421 | AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE | Ambu, Inc. | 2004-02-27 | Traditional | PDF ↗ |
| K032051 | BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P | Access Battery, Inc. | 2004-01-09 | Traditional | PDF ↗ |
| K033144 | DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES | Defibtech, LLC | 2003-11-13 | Traditional | PDF ↗ |
| K033275 | LIFEPAK 12, 20, 500, CR PLUS | Medtronic Physio-Control Corp. | 2003-11-06 | Special | PDF ↗ |
| K032439 | ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) | Zoll Medical Corp | 2003-11-05 | Abbreviated | PDF ↗ |
| K030898 | MOBILE BATTERY SERVICE STATION (MBSS) | Ad Elektronik GmbH | 2003-08-27 | Traditional | PDF ↗ |
| K031187 | HEARTSTART MRX, MODEL M3535A | Philips Medical Systems | 2003-08-27 | Abbreviated | PDF ↗ |
| K031987 | POWERHEART AED G3, MODEL 9300 | Cardiac Science | 2003-07-30 | Special | PDF ↗ |
| K023854 | SAMARITAN AED, MODEL SAM-01 | Heartsine Technologies, Inc. | 2003-02-14 | Traditional | PDF ↗ |
| K022929 | PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210 | Cardiac Science, Inc. | 2003-01-27 | Traditional | PDF ↗ |
| K022732 | INFANT/CHILD REDUCED ENERGY ELECTRODES | Medtronic Physio-Control Corp. | 2002-12-13 | Traditional | PDF ↗ |
| K020715 | PHILIPS M5066A AND M5068A | Philips Medical Systems | 2002-11-08 | Abbreviated | PDF ↗ |
| K022210 | MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650 | Cardiac Science, Inc. | 2002-10-04 | Traditional | PDF ↗ |
| K020984 | ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS | Access Cardiosystems, Inc. | 2002-08-14 | Traditional | PDF ↗ |
| K021453 | HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A | Philips Medical Systems | 2002-07-03 | Traditional | PDF ↗ |
| K021168 | JUMP START, MODEL 970300 | Medical Research Laboratories, Inc. | 2002-06-26 | Traditional | PDF ↗ |
| K013896 | SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA | Defibtech, LLC | 2002-06-19 | Traditional | PDF ↗ |
| K020743 | PADPRO, MODEL 2502 | Padpro, LLC | 2002-05-28 | Traditional | PDF ↗ |
| K020203 | PADPRO MODEL #2516 | Padpro, LLC | 2002-05-08 | Special | PDF ↗ |
| K011541 | ZOLL PAD WITH CPR AID | Zoll Medical Corp | 2002-04-11 | Traditional | PDF ↗ |
| K011388 | ZOLL PAD | Zoll Medical Corp | 2002-03-25 | Traditional | PDF ↗ |
| K020288 | PADPRO, MODEL 2603 | Padpro, LLC | 2002-02-27 | Special | PDF ↗ |
| K011901 | FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200 | Survivalink Corp. | 2002-02-01 | Traditional | PDF ↗ |
| K012766 | PORTABLE INTENSIVE CARE UNIT | Medical Research Laboratories, Inc. | 2002-01-23 | Traditional | PDF ↗ |
| K014209 | PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS | Padpro, LLC | 2002-01-18 | Special | PDF ↗ |
| K014157 | HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A | Philips Medical Systems | 2002-01-17 | Special | PDF ↗ |
| K013425 | HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A | Philips Medical Systems | 2002-01-14 | Traditional | PDF ↗ |
| K011144 | LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR | Medtronic Physio-Control Corp. | 2001-12-03 | Traditional | PDF ↗ |
| K012197 | POWERHEART CARDIAC RHYTHM MODULE | Cardiac Science, Inc. | 2001-11-16 | Traditional | PDF ↗ |
| K012428 | MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR | Medtronic Physio-Control Corp. | 2001-09-28 | Special | PDF ↗ |
| K012030 | PORTABLE INTENSIVE CARE UNIT | Medical Research Laboratories, Inc. | 2001-09-24 | Traditional | PDF ↗ |
| K003548 | PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS | Padpro, LLC | 2001-09-04 | Traditional | PDF ↗ |
| K010918 | LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM | Medtronic Physio-Control Corp. | 2001-08-23 | Traditional | PDF ↗ |
| K010207 | PORTABLE INSTENSIVE CARE UNIT | Medical Research Laboratories, Inc. | 2001-06-14 | Special | PDF ↗ |
| K010634 | HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B | Agilent Technologies, Inc. | 2001-06-11 | Traditional | PDF ↗ |
| K003819 | HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A | Agilent Technologies, Inc. | 2001-05-02 | Traditional | PDF ↗ |
| K010257 | ZOLL M SERIES | Zoll Medical Corp | 2001-02-28 | Special | PDF ↗ |
| K010214 | FIRSTSAVE BIPHASIC MODEL #9200 AND 9210 | Survivalink Corp. | 2001-02-22 | Special | PDF ↗ |
| K002079 | MULTI-FUNCTION DEFIBRILLATION ELECTRODE | Medicotest A/S | 2001-02-22 | Traditional | PDF ↗ |
| K002280 | PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 | Medical Devices, Inc. | 2001-02-05 | Traditional | PDF ↗ |
| K002445 | LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES | Medtronic Physio-Control Corp. | 2001-01-31 | Traditional | PDF ↗ |
| K003565 | HEARTSTREAM FR2 AED, MODEL M3860A,M3861A | Agilent Technologies, Inc. | 2000-12-20 | Special | PDF ↗ |
| K003228 | K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A | Katecho, Inc. | 2000-12-14 | Traditional | PDF ↗ |
| K002232 | AEDEFIBRILLATOR | Medical Research Laboratories, Inc. | 2000-12-06 | Traditional | PDF ↗ |
| K002806 | K-DEFIB/PACE, MODEL KDP-60A | Katecho, Inc. | 2000-11-21 | Traditional | PDF ↗ |
| K000638 | RESPONDER 3000 | Ge Medical Systems Information Technologies GmbH | 2000-10-30 | Traditional | PDF ↗ |
| K001725 | HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A | Agilent Technologies, Inc. | 2000-09-08 | Traditional | PDF ↗ |
| K992543 | HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE | Hewlett-Packard Co. | 2000-05-18 | Traditional | PDF ↗ |
| K993036 | ZOLL M SERIES ETCO2 OPTION | Zoll Medical Corp | 2000-02-28 | Traditional | PDF ↗ |
| K993745 | K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80 | Katecho, Inc. | 2000-02-03 | Traditional | PDF ↗ |
| K993533 | POWERHEART AECD | Cardiac Science, Inc. | 2000-01-24 | Special | PDF ↗ |
| K993072 | SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630) | Survivalink Corp. | 1999-12-10 | Traditional | PDF ↗ |
| K992977 | HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A | Hewlett-Packard Co. | 1999-12-01 | Traditional | PDF ↗ |
| K991556 | ZOLL M SERIES 12SL ANALYSIS OPTION | Zoll Medical Corp | 1999-10-21 | Traditional | PDF ↗ |
| K991910 | LIFEPAK 12 BIPHASIC | Physio-Control Corp. | 1999-09-03 | Traditional | PDF ↗ |
| K990762 | ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) | Zoll Medical Corp | 1999-09-03 | Traditional | PDF ↗ |
| K991007 | K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 | Katecho, Inc. | 1999-08-23 | Traditional | PDF ↗ |
| K991871 | HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A | Hewlett-Packard Co. | 1999-08-05 | Traditional | PDF ↗ |
| K983393 | LIFEPAK 500 BIPHASIC | Physio-Control Corp. | 1999-05-05 | Traditional | PDF ↗ |
| K984582 | ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX | Bio-Detek, Inc. | 1999-03-16 | Traditional | PDF ↗ |
| K982992 | ZOLL M SERIES SPO2 OPTION | Zoll Medical Corp | 1999-03-11 | Traditional | PDF ↗ |
| K990106 | ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES | Bio-Detek, Inc. | 1999-02-26 | Traditional | PDF ↗ |
| K982264 | FIRSTSAVE BIPHASIC MODELS 9200 AND 9210 | Survivalink Corp. | 1999-01-25 | Traditional | PDF ↗ |
| K984286 | HEARTSTREAM ELECTRODE ADAPTER | Hewlett-Packard Co. | 1998-12-17 | Special | PDF ↗ |
| K981737 | K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60 | Katecho, Inc. | 1998-12-09 | Traditional | PDF ↗ |
| K981802 | ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003 | Bio-Detek, Inc. | 1998-11-25 | Traditional | PDF ↗ |
| K983307 | MODIFICATION TO PORTABLE INTENSIVE CARE UNIT | Medical Research Laboratories, Inc. | 1998-11-20 | Special | PDF ↗ |
| K983287 | MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE | Graphic Controls Corp. | 1998-11-05 | Traditional | PDF ↗ |
| K982025 | HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR | Hewlett-Packard Co. | 1998-09-04 | Traditional | PDF ↗ |
| K982710 | AECD ARRHYTHMIA DETECTION SOFTWARE | Cardiac Science, Inc. | 1998-08-10 | Special | PDF ↗ |
| K965117 | LIFE SUPPORT FOR TRAUMA AND TRANSPORT | Northrop Grumman Corp. | 1998-06-26 | Traditional | PDF ↗ |
| K980857 | MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE | Graphic Controls Corp. | 1998-05-12 | Traditional | PDF ↗ |
| K972241 | ZOLL REVIVER | Zoll Medical Corp | 1998-03-16 | Traditional | PDF ↗ |
| K973486 | LIFE PAK 12 | Physio-Control Corp. | 1998-01-09 | Traditional | PDF ↗ |
| K962359 | LIFEPAK 300 | Physio-Control Corp. | 1997-11-06 | Traditional | PDF ↗ |
| K970741 | POWERHEART AECD | Cardiac Science, Inc. | 1997-10-16 | Traditional | PDF ↗ |
| K972418 | HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX) | Heartstream, Inc. | 1997-09-25 | Traditional | PDF ↗ |
| K972970 | MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE | Graphic Controls Corp. | 1997-08-27 | Traditional | PDF ↗ |
| K955890 | FIRST MEDIC PULSE OXIMETRY MODULE | Colorado Medtech, Inc. | 1997-07-28 | Traditional | PDF ↗ |
| K971149 | SVL-9130 DEFIBRILLATION ELECTRODE | Survivalink Corp. | 1997-06-23 | Traditional | PDF ↗ |
| K971148 | 700-SP SERIES DISPOSABLE STIMULATION ELECTRODES | Cardiotronics Systems, Inc. | 1997-05-15 | Traditional | PDF ↗ |
| K970719 | 700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES | Cardiotronics Systems, Inc. | 1997-04-16 | Traditional | PDF ↗ |
| K970391 | QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES | Contour Medical Technology, Inc. | 1997-03-06 | Traditional | PDF ↗ |
| K964991 | 700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES | Cardiotronics Systems, Inc. | 1997-01-15 | Traditional | PDF ↗ |
| K955854 | LIFEPAK 500 | Physio-Control Corp. | 1996-11-04 | Traditional | PDF ↗ |
| K955882 | MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORS | Graphic Controls Corp. | 1996-10-24 | Traditional | PDF ↗ |
| K955923 | MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL | Graphic Controls Corp. | 1996-10-24 | Traditional | PDF ↗ |
| K955628 | FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS | Heartstream, Inc. | 1996-09-10 | Traditional | PDF ↗ |
| K955828 | MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR PHYSIO CONTROL DEFIBRILLATORS | Graphic Controls Corp. | 1996-07-25 | Traditional | PDF ↗ |
Product code MKJ · Class III · Cardiovascular. Data: openFDA.