510(k) · Cleared
ClearedMedtronic Model 53401 External Pulse Generator (EPG)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DTE Pulse-Generator, Pacemaker, External
Cleared on Apr 19, 2018 as substantially equivalent to K162054 (Medtronic, Inc., 2016) after a 16-day review. Its family tree reaches back 2 generations to 2013.
- Decided
- Apr 19, 2018
- Review
- 16 days
- Class
- Class II
- Product code
- DTE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K132924 (2013). No later device cites it as a predicate yet.
- Root · 2 generations backK132924 Medtronic External Pulse Generator (Epg)Medtronic, Inc. · 2013 · Recalled
- 1 generation backK162054 Medtronic Temporary External Pacemaker 53401Medtronic, Inc. · 2016 · Recalled
- This deviceK180873 Medtronic Model 53401 External Pulse Generator (EPG)Medtronic, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
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
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 | Decided |
|---|---|---|---|
| * | K162054 | Medtronic Temporary External Pacemaker 53401Summary page 4…tion: Class II Classification Panel: Cardiovascular Special Controls: Not applicable Predicate Devices: Medtronic Model 53401 External Pulse Generator (EPG) K162054 K180873 2 of 3 Device De… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 3.0 years on median.
- 2 of the 2 ancestors have a recall of any class.
How does its category compare?
All DTE devicesDTE Pulse-Generator, Pacemaker, External: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DTE
1in 2025
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTE
636in 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 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…
Read the full statement (143 words)
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180873 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180873: Medtronic Model 53401 External Pulse Generator (EPG).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180873
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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