Atlas FDA

DTE

65 FDA 510(k) clearances · Product code

72 daysmedian time to decision
262 days90th percentile
65clearances measured

FDA profile

Official device name
Pulse-Generator, Pacemaker, External
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3600
Medical specialty
Cardiovascular
Adverse events (MAUDE)
2021: 899 · 2022: 833 · 2023: 650 · 2024: 620 · 2025: 643 · 2026: 324
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Solo Pace Control (K241781)Solo Pace, Inc.2025-01-10
Lifetech Cardio Temporary Pacemaker (K232721)Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.2024-01-07
Medtronic Model 5392 External Pulse Generator (EPG) (K201011)Medtronic, Inc.2020-05-13
Medtronic Model 5392 External Pulse Generator (EPG) (K190825)Medtronic, Inc.2019-04-30
Lifetech Cardio Model 8301 Temporary Pacemaker (K182839)Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.2019-02-28
Medtronic Model 5392 External Pulse Generator (EPG) (K181973)Medtronic, Inc.2018-08-21
Medtronic Model 53401 External Pulse Generator (EPG) (K180873)Medtronic, Inc.2018-04-19
Medtronic Temporary External Pacemaker 53401 (K162054)Medtronic, Inc.2016-10-18
Medtronic Model 5392 External Pulse Generator (EPG) (K162550)Medtronic, Inc.2016-10-12
Medtronic Model 5392 External Pulse Generator (EPG) (K150246)Medtronic, Inc.2015-02-18
MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) (K132924)Medtronic, Inc.2013-10-31
PSA SERIES (K123916)Osypka Medical, Inc.2013-04-09
ERA 3000 PACING SYSTEM ANALYZER (K042708)Biotronik, Inc.2004-10-20
PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR (K033130)Osypka Medical, Inc.2003-10-31
GALIX PACESTAR (K023080)Galix Biomedical Instrumentation, Inc.2003-06-11
OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES (K022939)Osypka Medical, Inc.2002-10-03
OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE (K020896)Osypka Medical, Inc.2002-06-14
ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 (K011980)Pace Medical2001-09-12
PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V (K002204)Pace Medical2000-10-18
TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 (K001180)Pace Medical2000-06-27
MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM (K970347)Paladin Medical, Inc.1997-08-29
MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL (K971474)Medtronic Vascular1997-07-14
ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER (K964190)Biotronik, Inc.1997-07-10
PACE 101H (K970497)Sulzer Oscor, Inc.1997-06-04
ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004 (K960676)Zoll Medical Corp1996-06-05
REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601 (K940467)Remington Medical, Inc.1994-11-01
POWERCHARGER (K934016)Zoll Medical Corp1994-10-18
MODEL 4800 ACCUPACE PACING SYSTEM ANALYER (K925143)Pace Medical1994-09-27
EXTERNAL DEMAND PACEMAKER (K923621)Oscor Medical Corp.1993-05-19
CPI MODEL 2215 (K923398)Seamed Corp.1992-08-14
CHRONOCOR VI MODEL 5012 (K915364)Seamed Corp.1992-02-07
MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER (K913805)Pace Medical1991-11-19
CPI MODEL 2215 & SEAMED MODEL 3400 (K912507)Seamed Corp.1991-09-03
MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR (K910237)Medtronic Vascular1991-02-25
MODELS 4201, 4231 & 4235 EXTENSION CABLES (K902679)Pace Medical1990-07-19
TRANS-PACE 100 (K900220)Synchromed Corp.1990-07-17
MODEL EC4542G MINIATURE (K896352)Pace Medical1990-01-24
MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE (K893633)Medtronic Vascular1989-06-20
SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY (K883930)Seamed Corp.1988-11-09
SEAMED MODEL 3200 (K872551)Seamed Corp.1987-07-31
MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543 (K871915)Pace Medical1987-06-10
ERA-20 (K853194)Biotronik Sales, Inc.1987-03-11
MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER (K870323)Pace Medical1987-03-03
SEA MED MODEL 6000 (K863903)Seamed Corp.1986-12-10
SEAMED MODEL 4000 (K854648)Seamed Corp.1986-01-16
CHRONOCOR V EXTERNAL PACER, MODEL 297A (K850822)Seamed Corp.1985-07-16
SEAMED MODEL 6000 (K843807)Seamed Corp.1985-02-01
SEAMED 4000 (K843777)Seamed Corp.1985-02-01
EXTERNAL PULSE GENERATOR FOR TEMP. STIM (K831768)Oscor, Inc.1983-12-16
RAPID ATRIAL PACER (K831381)Seamed Corp.1983-08-31
SEA MED MODEL 880 (K823048)Seamed Corp.1982-12-15
EXTERNAL PULSE GENERATOR - EV4542 (K821791)American Pacemaker Corp.1982-07-06
SEAMED, #540 - SIEMENS, #146F TELECTRO (K820570)Seamed Corp.1982-06-03
STERILE PACKAGING (K811092)Telectronics, Inc.1981-07-01
SIEMENS MODEL 146-146A EXTERNAL PULSE G (K810566)Cynergy1981-04-01
PACING SYSTEM ANALYZER (K803313)Medtronic Vascular1981-02-23
CHRONOCOR IV MODEL 250 (K802221)Cordis Corp.1980-11-19
COMPUPACE, 524-01 PACER SYSTEM COMPUTER (K801055)Intermedics, Inc.1980-10-31
EXTERNAL, TEMP. PORTABLE CARDIAC GENER (K801953)Telectronics, Inc.1980-10-23
CYNERGY MODEL 184 (K801596)Cynergy1980-09-16
CYNERGY MODEL 182 (K792536)Cynergy1980-01-31
PACEMAKER ELECTRODE INSERTER AIDE (K800088)Telectronics, Inc.1980-01-29
PACESETTER MODEL 350 (K792223)Cynergy1979-11-30
MEDTRONIC MODEL 546 (K782108)Medtronic Vascular1978-12-29
PULSE GENERATOR, MODEL 240, EXTERNAL (K781327)Intermedics, Inc.1978-12-11

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