Product Code: DTE FDA class 2 21 CFR 870.3600

Pulse-Generator, Pacemaker, External

Cardiovascular

The External Pacemaker Pulse Generator is a cardiovascular device used outside the body to deliver temporary pacing impulses to the heart through electrode leads, typically during emergency situations, perioperative care, or while awaiting implantation of a permanent pacemaker. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DTE and it is regulated under 21 CFR 870.3600 within the Cardiovascular medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: DTE
Device Class: FDA class 2
Regulation Number: 870.3600
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 65 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K241781	Solo Pace Control	Jan 10, 2025	Substantially Equivalent	Solo Pace, Inc.
K232721	Lifetech Cardio Temporary Pacemaker	Jan 07, 2024	Substantially Equivalent	Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.
K201011	Medtronic Model 5392 External Pulse Generator (EPG)	May 13, 2020	Substantially Equivalent	Medtronic, Inc.
K190825	Medtronic Model 5392 External Pulse Generator (EPG)	Apr 30, 2019	Substantially Equivalent	Medtronic, Inc.
K182839	Lifetech Cardio Model 8301 Temporary Pacemaker	Feb 28, 2019	Substantially Equivalent	Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.
K181973	Medtronic Model 5392 External Pulse Generator (EPG)	Aug 21, 2018	Substantially Equivalent	Medtronic, Inc.
K180873	Medtronic Model 53401 External Pulse Generator (EPG)	Apr 19, 2018	Substantially Equivalent	Medtronic, Inc.
K162054	Medtronic Temporary External Pacemaker 53401	Oct 18, 2016	Substantially Equivalent	Medtronic, Inc.
K162550	Medtronic Model 5392 External Pulse Generator (EPG)	Oct 12, 2016	Substantially Equivalent	Medtronic, Inc.
K150246	Medtronic Model 5392 External Pulse Generator (EPG)	Feb 18, 2015	Substantially Equivalent	Medtronic, Inc.
K132924	MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)	Oct 31, 2013	Substantially Equivalent	Medtronic, Inc.
K123916	PSA SERIES	Apr 09, 2013	Unknown	Osypka Medical, Inc.
K042708	ERA 3000 PACING SYSTEM ANALYZER	Oct 20, 2004	Substantially Equivalent	Biotronik, Inc.
K033130	PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR	Oct 31, 2003	Substantially Equivalent	Osypka Medical, Inc.
K023080	GALIX PACESTAR	Jun 11, 2003	Substantially Equivalent	Galix Biomedical Instrumentation, Inc.
K022939	OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES	Oct 03, 2002	Substantially Equivalent	Osypka Medical, Inc.
K020896	OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE	Jun 14, 2002	Substantially Equivalent	Osypka Medical, Inc.
K011980	ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825	Sep 12, 2001	Substantially Equivalent	Pace Medical
K002204	PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V	Oct 18, 2000	Substantially Equivalent	Pace Medical
K001180	TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528	Jun 27, 2000	Substantially Equivalent	Pace Medical
K970347	MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM	Aug 29, 1997	Substantially Equivalent	Paladin Medical, Inc.
K971474	MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL	Jul 14, 1997	Substantially Equivalent	Medtronic Vascular
K964190	ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER	Jul 10, 1997	Substantially Equivalent	Biotronik, Inc.
K970497	PACE 101H	Jun 04, 1997	Substantially Equivalent	Sulzer Oscor, Inc.
K960676	ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004	Jun 05, 1996	Substantially Equivalent	Zoll Medical Corp
K940467	REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601	Nov 01, 1994	Substantially Equivalent	Remington Medical, Inc.
K934016	POWERCHARGER	Oct 18, 1994	Substantially Equivalent	Zoll Medical Corp
K925143	MODEL 4800 ACCUPACE PACING SYSTEM ANALYER	Sep 27, 1994	Substantially Equivalent	Pace Medical
K923621	EXTERNAL DEMAND PACEMAKER	May 19, 1993	Substantially Equivalent	Oscor Medical Corp.
K923398	CPI MODEL 2215	Aug 14, 1992	Substantially Equivalent	Seamed Corp.
K915364	CHRONOCOR VI MODEL 5012	Feb 07, 1992	Substantially Equivalent	Seamed Corp.
K913805	MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER	Nov 19, 1991	Substantially Equivalent	Pace Medical
K912507	CPI MODEL 2215 & SEAMED MODEL 3400	Sep 03, 1991	Substantially Equivalent	Seamed Corp.
K910237	MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR	Feb 25, 1991	Substantially Equivalent	Medtronic Vascular
K902679	MODELS 4201, 4231 & 4235 EXTENSION CABLES	Jul 19, 1990	Substantially Equivalent	Pace Medical
K900220	TRANS-PACE 100	Jul 17, 1990	Substantially Equivalent	Synchromed Corp.
K896352	MODEL EC4542G MINIATURE	Jan 24, 1990	Substantially Equivalent	Pace Medical
K893633	MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE	Jun 20, 1989	Substantially Equivalent	Medtronic Vascular
K883930	SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY	Nov 09, 1988	Substantially Equivalent	Seamed Corp.
K872551	SEAMED MODEL 3200	Jul 31, 1987	Substantially Equivalent	Seamed Corp.
K871915	MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543	Jun 10, 1987	Substantially Equivalent	Pace Medical
K853194	ERA-20	Mar 11, 1987	Substantially Equivalent	Biotronik Sales, Inc.
K870323	MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER	Mar 03, 1987	Substantially Equivalent	Pace Medical
K863903	SEA MED MODEL 6000	Dec 10, 1986	Substantially Equivalent	Seamed Corp.
K854648	SEAMED MODEL 4000	Jan 16, 1986	Substantially Equivalent	Seamed Corp.
K850822	CHRONOCOR V EXTERNAL PACER, MODEL 297A	Jul 16, 1985	Substantially Equivalent	Seamed Corp.
K843807	SEAMED MODEL 6000	Feb 01, 1985	Substantially Equivalent	Seamed Corp.
K843777	SEAMED 4000	Feb 01, 1985	Substantially Equivalent	Seamed Corp.
K831768	EXTERNAL PULSE GENERATOR FOR TEMP. STIM	Dec 16, 1983	Substantially Equivalent	Oscor, Inc.
K831381	RAPID ATRIAL PACER	Aug 31, 1983	Substantially Equivalent	Seamed Corp.
K823048	SEA MED MODEL 880	Dec 15, 1982	Substantially Equivalent	Seamed Corp.
K821791	EXTERNAL PULSE GENERATOR - EV4542	Jul 06, 1982	Substantially Equivalent	American Pacemaker Corp.
K820570	SEAMED, #540 - SIEMENS, #146F TELECTRO	Jun 03, 1982	Substantially Equivalent	Seamed Corp.
K811092	STERILE PACKAGING	Jul 01, 1981	Substantially Equivalent	Telectronics, Inc.
K810566	SIEMENS MODEL 146-146A EXTERNAL PULSE G	Apr 01, 1981	Substantially Equivalent	Cynergy
K803313	PACING SYSTEM ANALYZER	Feb 23, 1981	Substantially Equivalent	Medtronic Vascular
K802221	CHRONOCOR IV MODEL 250	Nov 19, 1980	Substantially Equivalent	Cordis Corp.
K801055	COMPUPACE, 524-01 PACER SYSTEM COMPUTER	Oct 31, 1980	Substantially Equivalent	Intermedics, Inc.
K801953	EXTERNAL, TEMP. PORTABLE CARDIAC GENER	Oct 23, 1980	Substantially Equivalent	Telectronics, Inc.
K801596	CYNERGY MODEL 184	Sep 16, 1980	Substantially Equivalent	Cynergy
K792536	CYNERGY MODEL 182	Jan 31, 1980	Substantially Equivalent	Cynergy
K800088	PACEMAKER ELECTRODE INSERTER AIDE	Jan 29, 1980	Substantially Equivalent	Telectronics, Inc.
K792223	PACESETTER MODEL 350	Nov 30, 1979	Substantially Equivalent	Cynergy
K782108	MEDTRONIC MODEL 546	Dec 29, 1978	Substantially Equivalent	Medtronic Vascular
K781327	PULSE GENERATOR, MODEL 240, EXTERNAL	Dec 11, 1978	Substantially Equivalent	Intermedics, Inc.