510(k) · Cleared
ClearedMedtronic Model 5392 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 May 13, 2020 as substantially equivalent to K190825 (Medtronic, Inc., 2019) after a 26-day review. Its family tree reaches back 5 generations to 2013.
- Decided
- May 13, 2020
- Review
- 26 days
- Class
- Class II
- Product code
- DTE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K132924 (2013). No later device cites it as a predicate yet.
- Root · 5 generations backK132924 Medtronic External Pulse Generator (Epg)Medtronic, Inc. · 2013 · Recalled
- 4 generations backK150246 Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2015 · Recalled
- 3 generations backK162550 Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2016
- 2 generations backK181973 Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2018
- 1 generation backK190825 Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2019
- This deviceK201011 Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K132924 | Medtronic External Pulse Generator (Epg) | Medtronic, Inc. | 2013 | 1 |
| −4 | K150246 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2015 | 1 |
| −3 | K162550 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2016 | — |
| −2 | K181973 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2018 | — |
| −1 | K190825 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2019 | — |
| 0 (this device) | K201011 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2020 | — |
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
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 |
|---|---|---|---|
| * | K190825 | Medtronic Model 5392 External Pulse Generator (EPG)Summary page 3…Center for Devices and Radiological Health Enclosure Indications for Use 510(k) Number: K190825 Device Name: Medtronic Model 5392 External Pulse Generator (EPG) Indications for Use: The temporary pacemaker is used with a ca… | 2019 |
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 7 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
- 2 of the 5 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. 2020, 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 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…
Read the full statement (152 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201011: Medtronic Model 5392 External Pulse Generator (EPG).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201011
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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