Atlas FDA

DRO

84 FDA 510(k) clearances · Product code

88 daysmedian time to decision
235 days90th percentile
84clearances measured

FDA profile

Official device name
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5550
Medical specialty
Cardiovascular
Flags
Life-sustaining
Adverse events (MAUDE)
2016: 49 · 2017: 15 · 2018: 64 · 2019: 93 · 2020: 19 · 2021: 22
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES (K012218)The Ludlow Company LP2001-10-12
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 (K012404)Katecho, Inc.2001-10-12
ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413 (K000660)Medical Data Electronics2000-03-28
PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) (K983196)Tz Medical, Inc.1999-09-15
PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT (K983232)Tz Medical, Inc.1999-09-15
PORTABLE INTENSIVE CARE UNIT (K974034)Medical Research Laboratories, Inc.1998-03-02
CARDIOSERV P (K962547)Marquette Electronics, Inc.1997-03-06
RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM (K963120)Marquette Electronics, Inc.1997-02-28
ESORT II + 400 SERIES MONITOR (K961138)Medical Data Electronics1996-12-10
ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000 (K950856)Zoll Medical Corp1995-12-29
LIFEPAK 11 (K951593)Physio-Control Corp.1995-12-29
HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR (K950483)Hewlett-Packard Co.1995-05-22
K-DEFIB/PACE CARBON ELECTRODE (K926175)Katecho, Inc.1993-04-15
MODELS M1722A, M1723A, M1724A DEFIBRILLATORS (K915757)Hewlett-Packard Co.1992-07-30
GEL-TAC (K915328)Katecho, Inc.1992-06-29
K-DEFIB/PACE ELECTRODE (K914955)Katecho, Inc.1992-05-14
QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC (K912599)Physio-Control Corp.1991-09-11
ZOLL PD-1400 PACER/DEFIBRILLATOR (K911956)Zmi Corp.1991-07-31
MODEL 205 SHOCK-TRODE (K910661)Cardiotronics, Inc.1991-05-02
DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER (K903437)Keller Medical Specialties Products, Inc.1990-11-16
NKA MODEL SEC-3102 CARDIAC STIMULATOR (K894492)Nihon Kohden America, Inc.1989-12-20
DEFIB/PACING PADS (K894588)Conmedcorp1989-10-26
R2 PACE PAD, MODEL 480 (K895729)Darox Corp.1989-10-12
R2 PACE ADAPTOR CABLE, MODEL 196 (K895728)Darox Corp.1989-10-12
ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES (K885166)Zmi Corp.1989-05-01
MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE (K885171)Andover Medical, Inc.1989-01-12
MRL PACETTE, 450SLL (K880932)Medical Research Laboratories, Inc.1988-12-16
TRIAD-EP II, PUSHBUTTON, CABLE INPUT (K884532)Cardiotronics, Inc.1988-11-18
TRIAD-EP II, PLATE INPUT (K884530)Cardiotronics, Inc.1988-11-17
TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE (K883178)Cardiotronics, Inc.1988-11-09
TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY (K883304)Cardiotronics, Inc.1988-11-09
TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE (K883523)Cardiotronics, Inc.1988-10-06
QUIK-PACE II ELECTRODES (K883121)Physio-Control Corp.1988-09-20
MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE (K882338)Cardiotronics, Inc.1988-08-30
MODEL #918 MULTI-PADS (K883375)Cardiotronics, Inc.1988-08-30
EXTERNAL PACEMAKER 2000 (EP2000) (K882168)Unomed, Inc.1988-08-19
TRIAD-EP (K880936)Cardiotronics, Inc.1988-07-18
DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC (K874447)Medac, Inc.1988-01-27
QUIK-PACE NONINVASIVE PACEMAKER (K871751)Physio-Control Corp.1987-12-29
300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER (K874090)Medac, Inc.1987-12-15
ZOLL NTP-1200 PACER/DEFIBRILLATOR (K873402)Zmi Corp.1987-11-23
PACESTART (K872778)Pacific Rim Engineering & Mfg.1987-11-04
MODIFIED VERSA STIM ELECTRODE LINE (K872368)Conmedcorp1987-09-18
LECTEC NON-INVASIVE PACING ELECTRODE (K872012)Lectec Corp.1987-06-29
MODIFIED PACE*AID MODEL 53 (K871971)Cardiac Resucitator Corp.1987-06-24
STAT-PAD (TM) (K871538)Cardiac Resucitator Corp.1987-06-24
MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR (K871569)Cardiac Resucitator Corp.1987-06-08
PACE 10 NON-INVASIVE EXTERNAL PACEMAKER (K871176)Medac, Inc.1987-04-23
DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE (K864985)Medac, Inc.1987-03-10
ETP 180A NON-INVASIVE EXTERNAL PACEMAKER (K864989)Medac, Inc.1987-03-03
ETP 300 NON-INVASIVE EXTERNAL PACEMAKER (K864986)Medac, Inc.1987-03-03
DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE (K864987)Medac, Inc.1987-03-03
ETP 180E NON-INVASIVE EXTERNAL PACEMAKER (K864988)Medac, Inc.1987-03-03
MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE (K863547)Medtronic Vascular1986-10-31
ALTERNATE SIZE E-Z-PACE ELECTRODE (K862298)Medtronic Vascular1986-07-11
DCI MODEL EP-2 CLINICAL STIMULATOR (K854196)Digital Cardiovascular Instruments, Inc.1986-05-01
ETP 180 CARDIAC PACEMAKER (EXTERNAL) (K860551)Biotronics Corp.1986-04-30
NONINVASIVE TEMP. PACEMAKER NTP-1000 (K855015)Zmi Corp.1986-03-31
AMI CARDIO-PAD (K860283)Andover Medical, Inc.1986-03-31
AMI E-Z-PACE ELECTODE (K854924)A.M.I. Corp.1986-02-26
NI-PACER 1 (K854853)Associated Medical Devices, Inc.1986-02-14
AMENDMENT LIFEPAK 8, NPN 052 (K854117)Physio-Control Corp.1986-01-13
CMI 3000 (K854233)Cardio Management, Inc.1986-01-08
LIFEPAK 8 MODIFICATION (K853732)Physio-Control Corp.1985-12-09
EMERGIPACE - EXTERNAL PACEMAKER (K850812)Life Science Instrumentation, Inc.1985-11-05
PACEPAC (K852958)Medical Data Electronics1985-10-11
MDI 2000 - PULSE GENERATOR (K850791)Micromedical Devices, Inc.1985-06-19
AMENDMENT LIFEPAK 100, NPN 045 (K851248)Physio-Control Corp.1985-04-19
AMENDMENT LIFEPAK 200, NPN 046 (K851247)Physio-Control Corp.1985-04-19
PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY & (K850596)Cardiac Resucitator Corp.1985-03-06
HEART AID MODEL 97 (K850170)Cardiac Resucitator Corp.1985-02-14
PACE AID MODEL 53 (K844811)Cardiac Resucitator Corp.1985-01-24
PACE *AID MODEL 52 (K843547)Cardiac Resucitator Corp.1984-12-17
HEART-AID MODEL 80 (K843358)Cardiac Resucitator Corp.1984-11-19
PACEMAKER PULSE GENERATOR W/ELECTRODE (K840353)Ross Research, Inc.1984-04-23
LIFEPAK 7D (K840047)Physio-Control Corp.1984-02-04
TRANS-PACE (K834262)Micromedical Devices, Inc.1984-02-04
LIFEPAK 7P (K832876)Physio-Control Corp.1984-01-30
HEART*AID, ALS, MODEL 95 (K821673)Cardiac Resucitator Corp.1982-08-06
HEART AID #90 (K821152)Cardiac Resucitator Corp.1982-08-06
HEART *AID, #80 (K820609)Cardiac Resucitator Corp.1982-08-06
NONINVASIVE TEMPORARY PACEMAKER (K822246)Ross Research, Inc.1982-08-06
PACE* AID MODEL 50 (K820507)Cardiac Resucitator Corp.1982-08-06
PACE *AID (K813553)Cardiac Resucitator Corp.1982-01-18

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Every clearance here is in the API, with alerts when new ones post.