Product code DTE— Cardiovascular
Medtronic Model 5392 External Pulse Generator (EPG)
- Classification name
- Pulse-Generator, Pacemaker, External
- Device class
- Class 2
- Regulation
- 21 CFR 870.3600
- Advisory panel
- Cardiovascular
- Total cleared
- 65
- First cleared
- Most recent
Market context for product code DTE
FDA has cleared devices under product code DTE between 1978 and 2025, filed by 22 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2024
- 2020
- 2019
- 2018
- 2016
- 2015
- 2013
- 2004
- 2003
- 2002
- 2001
- 2000
- 1997
- 1996
Top applicants under product code DTE
Adverse events under product code DTE
product code DTE- Death
- 18
- Injury
- 247
- Malfunction
- 4,603
- Total
- 4,868
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code DTE
- K241781 — Solo Pace Control
- K232721 — Lifetech Cardio Temporary Pacemaker
- K201011 — Medtronic Model 5392 External Pulse Generator (EPG)
- K190825 — Medtronic Model 5392 External Pulse Generator (EPG)
- K182839 — Lifetech Cardio Model 8301 Temporary Pacemaker
- K181973 — Medtronic Model 5392 External Pulse Generator (EPG)
- K180873 — Medtronic Model 53401 External Pulse Generator (EPG)
- K162054 — Medtronic Temporary External Pacemaker 53401
- K162550 — Medtronic Model 5392 External Pulse Generator (EPG)
- K150246 — Medtronic Model 5392 External Pulse Generator (EPG)
- K132924 — MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)
- K123916 — PSA SERIES
- K042708 — ERA 3000 PACING SYSTEM ANALYZER
- K033130 — PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR
- K023080 — GALIX PACESTAR
- K022939 — OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES
- K020896 — OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE
- K011980 — ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825
- K002204 — PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V
- K001180 — TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528
- K970347 — MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM
- K971474 — MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL
- K964190 — ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
- K970497 — PACE 101H
- K960676 — ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004
- K940467 — REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601
- K934016 — POWERCHARGER
- K925143 — MODEL 4800 ACCUPACE PACING SYSTEM ANALYER
- K923621 — EXTERNAL DEMAND PACEMAKER
- K923398 — CPI MODEL 2215
- K915364 — CHRONOCOR VI MODEL 5012
- K913805 — MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER
- K912507 — CPI MODEL 2215 & SEAMED MODEL 3400
- K910237 — MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR
- K902679 — MODELS 4201, 4231 & 4235 EXTENSION CABLES
- K900220 — TRANS-PACE 100
- K896352 — MODEL EC4542G MINIATURE
- K893633 — MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE
- K883930 — SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY
- K872551 — SEAMED MODEL 3200
- K871915 — MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543
- K853194 — ERA-20
- K870323 — MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER
- K863903 — SEA MED MODEL 6000
- K854648 — SEAMED MODEL 4000
- K850822 — CHRONOCOR V EXTERNAL PACER, MODEL 297A
- K843777 — SEAMED 4000
- K843807 — SEAMED MODEL 6000
- K831768 — EXTERNAL PULSE GENERATOR FOR TEMP. STIM
- K831381 — RAPID ATRIAL PACER
- K823048 — SEA MED MODEL 880
- K821791 — EXTERNAL PULSE GENERATOR - EV4542
- K820570 — SEAMED, #540 - SIEMENS, #146F TELECTRO
- K811092 — STERILE PACKAGING
- K810566 — SIEMENS MODEL 146-146A EXTERNAL PULSE G
- K803313 — PACING SYSTEM ANALYZER
- K802221 — CHRONOCOR IV MODEL 250
- K801055 — COMPUPACE, 524-01 PACER SYSTEM COMPUTER
- K801953 — EXTERNAL, TEMP. PORTABLE CARDIAC GENER
- K801596 — CYNERGY MODEL 184
- K792536 — CYNERGY MODEL 182
- K800088 — PACEMAKER ELECTRODE INSERTER AIDE
- K792223 — PACESETTER MODEL 350
- K782108 — MEDTRONIC MODEL 546
- K781327 — PULSE GENERATOR, MODEL 240, EXTERNAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.