# K162054: Medtronic Temporary External Pacemaker 53401

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Oct 18, 2016 after 85 days
- Product code: DTE (Pulse-Generator, Pacemaker, External)
- Device class: 2
- Regulation: 21 CFR 870.3600
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K132924 (2013). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132924: Medtronic External Pulse Generator (Epg), Medtronic, Inc. (2013) Summary page 4.

## Most influential descendants
- K180873: Medtronic Model 53401 External Pulse Generator (EPG) (2018), 0 descendants of its own

## Recalls of this device
- Jun 6, 2018 · Class II · Z-2317-2018: A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from programmed settings to nominal settings during use with a patient due to an unexpected Power on Reset 

## Indications for use
The Model 53401 SC EPG is intended to be used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylatic, or diagnostic purposes. Specification 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/K162054
Methodology: https://510kreport.com/methodology