DTE · Class II · 21 CFR 870.3600

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

Leading manufacturers include Medtronic, Inc., Medtronic Vascular and Shenzhen Lifetech Cardio Medical Electronics Co., Ltd..

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 Jul 14, 1997
MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL
K971474
Medtronic Vascular
Cardiovascular · 82d
Cleared Feb 25, 1991
MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR
K910237
Medtronic Vascular
Cardiovascular · 38d
Cleared Jun 20, 1989
MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE
K893633
Medtronic Vascular
Cardiovascular · 40d
Cleared Feb 23, 1981
PACING SYSTEM ANALYZER
K803313
Medtronic Vascular
Cardiovascular · 54d
Cleared Nov 19, 1980
CHRONOCOR IV MODEL 250
K802221
Cordis Corp.
Cardiovascular · 68d
Cleared Oct 31, 1980
COMPUPACE, 524-01 PACER SYSTEM COMPUTER
K801055
Intermedics, Inc.
Cardiovascular · 178d
Cleared Dec 29, 1978
MEDTRONIC MODEL 546
K782108
Medtronic Vascular
Cardiovascular · 10d
Cleared Dec 11, 1978
PULSE GENERATOR, MODEL 240, EXTERNAL
K781327
Intermedics, Inc.
Cardiovascular · 132d

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 →