510(k) · Cleared

Recalled · Class II · 2018

Medtronic Temporary External Pacemaker 53401

K162054510(k) TraditionalCleared Oct 18, 201685-day reviewClass II21 CFR 870.3600Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic, Inc. · DTE Pulse-Generator, Pacemaker, External

Cleared on Oct 18, 2016 as substantially equivalent to K132924 (Medtronic, Inc., 2013) after an 85-day review. Its family tree reaches back 1 generation to 2013. 1 later device descends from it. It has been recalled once.

Decided: Oct 18, 2016
Review: 85 days
Class: Class II
Product code: DTE
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K132924 (2013). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK132924 Medtronic External Pulse Generator (Epg)Medtronic, Inc. · 2013 · Recalled
This deviceK162054 Medtronic Temporary External Pacemaker 53401Medtronic, Inc. · 2016
Descendant · cites it directly · 0 of its ownK180873 Medtronic Model 53401 External Pulse Generator (EPG)Medtronic, Inc. · 2018

Most influential descendants

Showing 1 of 1 · See all

K180873Medtronic Model 53401 External Pulse Generator (EPG)Medtronic, Inc. · 2018 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K132924	Medtronic External Pulse Generator (Epg)	Medtronic, Inc.	2013	1
0 (this device)	K162054	Medtronic Temporary External Pacemaker 53401	Medtronic, Inc.	2016	—
+1	K180873	Medtronic Model 53401 External Pulse Generator (EPG)	Medtronic, Inc.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0

FIG. 1 — Lineage of K162054, 2013–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DTE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DTE device

#1 K232721 Lifetech Cardio Temporary Pacemakerscore 7.2 · 3 generations · no Class I recall
#2 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K132924	Medtronic External Pulse Generator (Epg) Summary page 4 …the following predicate device:  Medtronic Model 5392 Dual Chamber Temporary External Pacemaker, initially cleared via 510(k) application, reference number K132924 on October 31, 2013. Brief Device Description The Medtronic Temporary External Pacemaker Model 53401 (hereafter simply referred…	Medtronic, Inc.	2013	1

Also cleared against K132924: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K180873	Medtronic Model 53401 External Pulse Generator (EPG)	Medtronic, Inc.	2018	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 6, 2018	Class II	Z-2317-2018	Device Design	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 (POR).

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K180873 (Medtronic, Inc., 2018) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K132924.

How does its category compare?

All DTE devices

DTE Pulse-Generator, Pacemaker, External: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · DTE

1in 2025

2007high 2 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTE

Too few DTE 510(k)s in any year since 2007 to give a median.

Recalls per year · DTE

2in 2010

2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DTE

636in 2025

2007high 1,865 (2011) · low 17 (2007)2025

MAUDE reports naming product code DTE, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	17
2008	0	—	0	22
2009	0	—	0	39
2010	0	—	2	335
2011	0	—	0	1,865
2012	0	—	0	1,786
2013	2	—	0	98
2014	0	—	0	67
2015	1	—	0	342
2016	2	—	0	496
2017	0	—	0	654
2018	2	—	0	956
2019	2	—	0	1,001
2020	1	—	0	1,092
2021	0	—	0	899
2022	0	—	0	833
2023	0	—	0	650
2024	1	—	0	620
2025	1	—	0	636
2026	0	—	0	—

What is it indicated for?

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 •…

Read the full statement (143 words)

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K162054 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162054: Medtronic Temporary External Pacemaker 53401.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162054

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026