# K180873: Medtronic Model 53401 External Pulse Generator (EPG)

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Apr 19, 2018 after 16 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: 2 generations back to K132924 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162054: Medtronic Temporary External Pacemaker 53401, Medtronic, Inc. (2016) Summary page 4.

## Indications for use
The Medtronic Temporary External Pacemaker 53401 is intended to be used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. It can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic, or diagnostic purposes. Specific indications for temporary cardiac pacing include, but are not limited to, the following indications: . Complete heart block . Sinus bradycardia . Sick Sinus Syndrome . Bradycardia with congestive heart failure . Atrial and/or ventricular arrhythmias . Cardiac arrest . Temporary support, management, and evaluation of a patient prior to permanent pacemaker implantation . Support during permanent pacemaker replacement . Cardiac complications during invasive or surgical procedures . Temporary support of a patient following cardiac surgery . Acute myocardial infarction complicated by heart block . High-rate burst pacing for the treatment of supraventricular tachyarrhythmias

Source page: https://510kreport.com/device/K180873
Methodology: https://510kreport.com/methodology