DTE · Class II · 21 CFR 870.3600

FDA Product Code DTE: Pulse-generator, Pacemaker, External

Leading manufacturers include Seamed Corp., Pace Medical and Medtronic, Inc..

65
Total
65
Cleared
111d
Avg days
1978
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 204d recently vs 109d historically

FDA 510(k) Cleared Pulse-generator, Pacemaker, External Devices (Product Code DTE)

65 devices
1–24 of 65
Cleared Jan 10, 2025
Solo Pace Control
K241781
Solo Pace, Inc.
Cardiovascular · 204d
Cleared Jan 07, 2024
Lifetech Cardio Temporary Pacemaker
K232721
Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.
Cardiovascular · 124d
Cleared May 13, 2020
Medtronic Model 5392 External Pulse Generator (EPG)
K201011
Medtronic, Inc.
Cardiovascular · 26d
Cleared Apr 30, 2019
Medtronic Model 5392 External Pulse Generator (EPG)
K190825
Medtronic, Inc.
Cardiovascular · 29d
Cleared Feb 28, 2019
Lifetech Cardio Model 8301 Temporary Pacemaker
K182839
Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.
Cardiovascular · 142d
Cleared Aug 21, 2018
Medtronic Model 5392 External Pulse Generator (EPG)
K181973
Medtronic, Inc.
Cardiovascular · 28d
Cleared Apr 19, 2018
Medtronic Model 53401 External Pulse Generator (EPG)
K180873
Medtronic, Inc.
Cardiovascular · 16d
Cleared Oct 18, 2016
Medtronic Temporary External Pacemaker 53401
K162054
Medtronic, Inc.
Cardiovascular · 85d
Cleared Oct 12, 2016
Medtronic Model 5392 External Pulse Generator (EPG)
K162550
Medtronic, Inc.
Cardiovascular · 29d
Cleared Feb 18, 2015
Medtronic Model 5392 External Pulse Generator (EPG)
K150246
Medtronic, Inc.
Cardiovascular · 16d
Cleared Oct 31, 2013
MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)
K132924
Medtronic, Inc.
Cardiovascular · 43d
Cleared Apr 09, 2013
PSA SERIES
K123916
Osypka Medical, Inc.
Cardiovascular · 111d
Cleared Oct 20, 2004
ERA 3000 PACING SYSTEM ANALYZER
K042708
Biotronik, Inc.
Cardiovascular · 20d
Cleared Sep 12, 2001
ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825
K011980
Pace Medical
Cardiovascular · 79d
Cleared Oct 18, 2000
PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V
K002204
Pace Medical
Cardiovascular · 90d
Cleared Jun 27, 2000
TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528
K001180
Pace Medical
Cardiovascular · 77d
Cleared Aug 29, 1997
MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM
K970347
Paladin Medical, Inc.
Cardiovascular · 214d
Cleared Jul 14, 1997
MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL
K971474
Medtronic Vascular
Cardiovascular · 82d
Cleared Jul 10, 1997
ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
K964190
Biotronik, Inc.
Cardiovascular · 262d
Cleared Jun 04, 1997
PACE 101H
K970497
Sulzer Oscor, Inc.
Cardiovascular · 114d
Cleared Jun 05, 1996
ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004
K960676
Zoll Medical Corp
Cardiovascular · 106d
Cleared Nov 01, 1994
REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601
K940467
Remington Medical, Inc.
Cardiovascular · 272d
Cleared Oct 18, 1994
POWERCHARGER
K934016
Zoll Medical Corp
Cardiovascular · 426d
Cleared Sep 27, 1994
MODEL 4800 ACCUPACE PACING SYSTEM ANALYER
K925143
Pace Medical
Cardiovascular · 714d

About Product Code DTE - Regulatory Context

510(k) Submission Activity

65 total 510(k) submissions under product code DTE since 1978, with 65 receiving FDA clearance (average review time: 111 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - DTE Product Code

Recent submissions under DTE have taken an average of 204 days to reach a decision - up from 109 days historically. Manufacturers should account for longer review timelines in current project planning.

DTE devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →