# K201011: Medtronic Model 5392 External Pulse Generator (EPG)

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: May 13, 2020 after 26 days
- Product code: DTE (Pulse-Generator, Pacemaker, External)
- Device class: 2
- Regulation: 21 CFR 870.3600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K132924 (2013). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190825: Medtronic Model 5392 External Pulse Generator (EPG), Medtronic, Inc. (2019) Summary page 3.

## Indications for use
The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic or diagnostic purposes. The temporary pacemaker must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient. Specific indications for temporary cardiac pacing include, but are not limited to, the following: Complete heart block Sinus bradycardia Sick sinus syndrome Bradycardia with congestive heart failure Atrial and/or ventricular arrhythmias Cardiac arrest Support, management, and evaluation of a patient prior to permanent pacemaker Implantation Support during permanent pacemaker replacement Cardiac complications during invasive or surgical procedures Support following cardiac surgery Acute myocardial infarction complicated by heart block Atrial tachyarrhythmias that require high-rate burst pacing for treatment

Source page: https://510kreport.com/device/K201011
Methodology: https://510kreport.com/methodology