Atlas FDA

Medtronic Temporary External Pacemaker 53401

FDA 510(k) clearance K162054 · decided 2016-10-18

Clearance details

K-number
K162054
Device name
Medtronic Temporary External Pacemaker 53401
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2016-07-25
Decision date
2016-10-18
Days to decision
85 days
Clearance type
Traditional
Product code
DTE
Device class
2
Regulation number
870.3600
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mounds View, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Solo Pace Control (K241781)Solo Pace, Inc.2025-01-10
Lifetech Cardio Temporary Pacemaker (K232721)Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.2024-01-07
Medtronic Model 5392 External Pulse Generator (EPG) (K201011)Medtronic, Inc.2020-05-13
Medtronic Model 5392 External Pulse Generator (EPG) (K190825)Medtronic, Inc.2019-04-30
Lifetech Cardio Model 8301 Temporary Pacemaker (K182839)Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.2019-02-28
Medtronic Model 5392 External Pulse Generator (EPG) (K181973)Medtronic, Inc.2018-08-21
Medtronic Model 53401 External Pulse Generator (EPG) (K180873)Medtronic, Inc.2018-04-19
Medtronic Model 5392 External Pulse Generator (EPG) (K162550)Medtronic, Inc.2016-10-12
Medtronic Model 5392 External Pulse Generator (EPG) (K150246)Medtronic, Inc.2015-02-18
MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) (K132924)Medtronic, Inc.2013-10-31
PSA SERIES (K123916)Osypka Medical, Inc.2013-04-09
ERA 3000 PACING SYSTEM ANALYZER (K042708)Biotronik, Inc.2004-10-20

Recalls involving this device

RecordFirmDate
Single Chamber Temporary External Pacemaker, Model 53401 recall (Z-2317-2018)Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)2018-06-29

PMA approvals by this applicant

RecordFirmDate
SynchroMed Infusion System; Ascenda Intrathecal Catheters (P860004/S455)Medtronic, Inc.2025-12-22
Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense (P960009/S527)Medtronic, Inc.2025-12-22
Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (P010015/S574)Medtronic, Inc.2025-12-19
SynchroMed™ Infusion Systems (P860004/S453)Medtronic, Inc.2025-12-19
Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense (P960009/S526)Medtronic, Inc.2025-12-18
Activa™ Deep Brain Stimulation Therapy System (P960009/S514)Medtronic, Inc.2025-12-17
Aurora EV-ICD System (P220012/S061)Medtronic, Inc.2025-12-15
Activa™ Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense™ (P960009/S524)Medtronic, Inc.2025-12-08