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 Apr 30, 2019 as substantially equivalent to K181973 (Medtronic, Inc., 2018) after a 29-day review. Its family tree reaches back 4 generations to 2013. 1 later device descends from it.
- Decided
- Apr 30, 2019
- Review
- 29 days
- Class
- Class II
- Product code
- DTE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K132924 (2013). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK132924 Medtronic External Pulse Generator (Epg)Medtronic, Inc. · 2013 · Recalled
- 3 generations backK150246 Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2015 · Recalled
- 2 generations backK162550 Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2016
- 1 generation backK181973 Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2018
- This deviceK190825 Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK201011 Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K201011Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K132924 | Medtronic External Pulse Generator (Epg) | Medtronic, Inc. | 2013 | 1 |
| −3 | K150246 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2015 | 1 |
| −2 | K162550 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2016 | — |
| −1 | K181973 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2018 | — |
| 0 (this device) | K190825 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2019 | — |
| +1 | K201011 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
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 |
|---|---|---|---|
| * | K181973 | Medtronic Model 5392 External Pulse Generator (EPG)Summary page 4…ation: Class II Classification Panel: Cardiovascular Special Controls: Not applicable Predicate Devices: Medtronic Model 5392 External Pulse Generator (EPG) K181973 190825… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201011 | Medtronic Model 5392 External Pulse Generator (EPG) | 2020 | 0 |
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 6 years and passes through 1 company; a new generation was cleared every 1.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K201011 (Medtronic, Inc., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DTE devicesDTE Pulse-Generator, Pacemaker, External: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 (164 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190825 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190825: 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/K190825
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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