Pulse-Generator, Pacemaker, External
FDA product code DTE · Class II (moderate risk) · 21 CFR 870.3600 · Cardiovascular
65510(k) clearances
0PMA approvals
5recalls
Manufacturers
- Seamed Corp. 13
- Pace Medical 9
- Medtronic, Inc. 8
- Medtronic Vascular 5
- Cynergy 4
- Osypka Medical, Inc. 4
- Telectronics, Inc. 3
- Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. 2
- Intermedics, Inc. 2
- Biotronik, Inc. 2
- ZOLL Medical Corporation 2
- Oscor Medical Corp. 1
- Synchromed Corp. 1
- Remington Medical, Inc. 1
- Sulzer Oscor, Inc. 1
- Biotronik Sales, Inc. 1
- Paladin Medical, Inc. 1
- Oscor, Inc. 1
- Solo Pace, Inc. 1
- American Pacemaker Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241781 | Solo Pace ControlDTE · Traditional | Solo Pace, Inc. | 01/10/2025SE |
| K232721 | Lifetech Cardio Temporary PacemakerDTE · Special | Shenzhen Lifetech Cardio Medical Electronics… | 01/07/2024SE |
| K201011 | Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 05/13/2020SE |
| K190825 | Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 04/30/2019SE |
| K182839 | Lifetech Cardio Model 8301 Temporary PacemakerDTE · Traditional | Shenzhen Lifetech Cardio Medical Electronics… | 02/28/2019SE |
| K181973 | Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 08/21/2018SE |
| K180873 | Medtronic Model 53401 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 04/19/2018SE |
| K162054 | Medtronic Temporary External Pacemaker 53401DTE · Traditional | Medtronic, Inc. | 10/18/2016SE |
| K162550 | Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 10/12/2016SE |
| K150246 | Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 02/18/2015SE |
| K132924 | Medtronic External Pulse Generator (Epg)DTE · Traditional | Medtronic, Inc. | 10/31/2013SE |
| K123916 | Psa SeriesDTE · Traditional | Osypka Medical, Inc. | 04/09/2013SESK |
| K042708 | Era 3000 Pacing System AnalyzerDTE · Special | Biotronik, Inc. | 10/20/2004SE |
| K033130 | Pace 101/PACE 101H, Model 3077 Ssi Temporary Pulse GeneratorDTE · Special | Osypka Medical, Inc. | 10/31/2003SE |
| K023080 | Galix PacestarDTE · Traditional | Galix Biomedical Instrumentation, Inc. | 06/11/2003SE |
| K022939 | Oscor Pace 101/101H and Accessories, St.Jude Medical Model 3077 and…DTE · Special | Osypka Medical, Inc. | 10/03/2002SE |
| K020896 | Oscor Pace 203/PACE 203H Dual-Chamber Temporary Pacemaker, St. Jude Medical, Model 3085…DTE · Abbreviated | Osypka Medical, Inc. | 06/14/2002SE |
| K011980 | Adapter, Pacing Analyzer/Universal Pacing Adapter, Models 4820 and 4825DTE · Traditional | Pace Medical | 09/12/2001SE |
| K002204 | Pacemaker Extension Cable Models 4265,4265A, 4265V, 5265, 5265A, 5265VDTE · Traditional | Pace Medical | 10/18/2000SE |
| K001180 | Temporary Pacemaker Extension Cable, Models 5235, 5235A, 5235V, Temporary Pacemaker…DTE · Traditional | Pace Medical | 06/27/2000SE |
| K970347 | MPC (Model 7000) External Temporary Pacemaker SystemDTE · Traditional | Paladin Medical, Inc. | 08/29/1997SE |
| K971474 | Medtronic Model 5318 Temporary Pacemaker/Implant ToolDTE · Traditional | Medtronic Vascular | 07/14/1997SE |
| K964190 | Era 300 Dual Chamber Pacing System AnalyzerDTE · Traditional | Biotronik, Inc. | 07/10/1997SE |
| K970497 | Pace 101HDTE · Traditional | Sulzer Oscor, Inc. | 06/04/1997SE |
| K960676 | Zoll Statpadz Radiolucent Adult Multi-Fuction Electrodes Model 8900-4004DTE · Traditional | Zoll Medical Corp | 06/05/1996SE |
| K940467 | Remington Medical Disposable Extension Cable Fas-Loc FL-601DTE · Traditional | Remington Medical, Inc. | 11/01/1994SE |
| K934016 | PowerchargerDTE · Traditional | Zoll Medical Corp | 10/18/1994SE |
| K925143 | Model 4800 Accupace Pacing System AnalyerDTE · Traditional | Pace Medical | 09/27/1994SE |
| K923621 | External Demand PacemakerDTE · Traditional | Oscor Medical Corp. | 05/19/1993SE |
| K923398 | Cpi Model 2215DTE · Traditional | Seamed Corp. | 08/14/1992SE |
| K915364 | Chronocor Vi Model 5012DTE · Traditional | Seamed Corp. | 02/07/1992SE |
| K913805 | Miniature Models 4562/4563/4572/4573 PacemakerDTE · Traditional | Pace Medical | 11/19/1991SE |
| K912507 | Cpi Model 2215 & Seamed Model 3400DTE · Traditional | Seamed Corp. | 09/03/1991SE |
| K910237 | Modified Model 5330 Av Demand Pulse GeneratorDTE · Traditional | Medtronic Vascular | 02/25/1991SE |
| K902679 | Models 4201, 4231 & 4235 Extension CablesDTE · Traditional | Pace Medical | 07/19/1990SE |
| K900220 | Trans-Pace 100DTE · Traditional | Synchromed Corp. | 07/17/1990SE |
| K896352 | Model EC4542G MiniatureDTE · Traditional | Pace Medical | 01/24/1990SE |
| K893633 | Model 5330 External A-V Sequential Demand PulseDTE · Traditional | Medtronic Vascular | 06/20/1989SE |
| K883930 | Seamed Model 3300 Dual Chamber Pacing System AnalyDTE · Traditional | Seamed Corp. | 11/09/1988SE |
| K872551 | Seamed Model 3200DTE · Traditional | Seamed Corp. | 07/31/1987SE |
| K871915 | Miniature Temp. Cardiac Pacemakers EC4542 & EC4543DTE · Traditional | Pace Medical | 06/10/1987SE |
| K853194 | ERA-20DTE · Traditional | Biotronik Sales, Inc. | 03/11/1987SE |
| K870323 | Model EV4543 Miniature Temporary Cardiac PacemakerDTE · Traditional | Pace Medical | 03/03/1987SE |
| K863903 | Sea Med Model 6000DTE · Traditional | Seamed Corp. | 12/10/1986SE |
| K854648 | Seamed Model 4000DTE · Traditional | Seamed Corp. | 01/16/1986SE |
| K850822 | Chronocor V External Pacer, Model 297ADTE · Traditional | Seamed Corp. | 07/16/1985SE |
| K843807 | Seamed Model 6000DTE · Traditional | Seamed Corp. | 02/01/1985SE |
| K843777 | Seamed 4000DTE · Traditional | Seamed Corp. | 02/01/1985SE |
| K831768 | External Pulse Generator for Temp. StimDTE · Traditional | Oscor, Inc. | 12/16/1983SE |
| K831381 | Rapid Atrial PacerDTE · Traditional | Seamed Corp. | 08/31/1983SE |
| K823048 | Sea Med Model 880DTE · Traditional | Seamed Corp. | 12/15/1982SE |
| K821791 | External Pulse Generator - EV4542DTE · Traditional | American Pacemaker Corp. | 07/06/1982SE |
| K820570 | Seamed, #540 - Siemens, #146F TelectroDTE · Traditional | Seamed Corp. | 06/03/1982SE |
| K811092 | Sterile PackagingDTE · Traditional | Telectronics, Inc. | 07/01/1981SE |
| K810566 | Siemens Model 146-146A External Pulse GDTE · Traditional | Cynergy | 04/01/1981SE |
| K803313 | Pacing System AnalyzerDTE · Traditional | Medtronic Vascular | 02/23/1981SE |
| K802221 | Chronocor IV Model 250DTE · Traditional | Cordis Corp. | 11/19/1980SE |
| K801055 | Compupace, 524-01 Pacer System ComputerDTE · Traditional | Intermedics, Inc. | 10/31/1980SE |
| K801953 | External, Temp. Portable Cardiac GenerDTE · Traditional | Telectronics, Inc. | 10/23/1980SE |
| K801596 | Cynergy Model 184DTE · Traditional | Cynergy | 09/16/1980SE |
| K792536 | Cynergy Model 182DTE · Traditional | Cynergy | 01/31/1980SE |
| K800088 | Pacemaker Electrode Inserter AideDTE · Traditional | Telectronics, Inc. | 01/29/1980SE |
| K792223 | Pacesetter Model 350DTE · Traditional | Cynergy | 11/30/1979SE |
| K782108 | Medtronic Model 546DTE · Traditional | Medtronic Vascular | 12/29/1978SE |
| K781327 | Pulse Generator, Model 240, ExternalDTE · Traditional | Intermedics, Inc. | 12/11/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1945-2019 Class II | ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and…Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation or pacing… | Bio-Detek, Inc. | 05/28/2019Terminated |
| Z-2317-2018 Class II | Single Chamber Temporary External Pacemaker, Model 53401A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from programmed… | Medtronic Inc., Cardiac Rhythm and Heart… | 06/06/2018Terminated |
| Z-1356-2015 Class II | Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The…Possible performance issue when used with specific AA-sized (LR6) batteries. The negative terminal of a… | Medtronic Inc. Cardiac Rhythm Disease… | 03/17/2015Terminated |
| Z-2444-2010 | St. Jude Medical, Model 3085, Dual-Chamber External Pulse Generator The PACE 203H /…The recall was initiated after Osypka Medical received two (2) complaints from their Japanese distributor… | Osypka Medical Inc | 06/30/2010Terminated |
| Z-2443-2010 | Oscor PACE 203H, Dual-Chamber External Pulse Generator The PACE 203H / Model 3085…The recall was initiated after Osypka Medical received two (2) complaints from their Japanese distributor… | Osypka Medical Inc | 06/30/2010Terminated |