510(k) · Cleared
Recalled · Class II · 2015Medtronic 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 Feb 18, 2015 as substantially equivalent to K132924 (Medtronic, Inc., 2013) after a 16-day review. Its family tree reaches back 1 generation to 2013. 4 later devices descend from it. It has been recalled once.
- Decided
- Feb 18, 2015
- Review
- 16 days
- Class
- Class II
- Product code
- DTE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K132924 (2013). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK132924 Medtronic External Pulse Generator (Epg)Medtronic, Inc. · 2013 · Recalled
- This deviceK150246 Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2015
- Descendant · cites it directly · 3 of its ownK162550 Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK181973 Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK190825 Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2019
- Descendant · 4 generations on · 0 of its ownK201011 Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K162550Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2016 · cites it directly3descendants
- K181973Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2018 · 2 generations on2descendants
- K190825Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2019 · 3 generations on1descendant
- K201011Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2020 · 4 generations on0descendants
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) | K150246 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2015 | — |
| +1 | K162550 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2016 | — |
| +2 | K181973 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2018 | — |
| +3 | K190825 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2019 | — |
| +4 | K201011 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K132924 | Medtronic External Pulse Generator (Epg)Summary page 4…Classification: Class I1I Classification Panel: Cardiovascular Special Controls: Not applicable Predicate Devices: Medtronic Model 5392 External Pulse Generator (EPG) K132924 Update Battery Box Design for 5392 EPG Kxxxxxx Medtronic Confidential 1-22 Device Description The Model 5392 EPG… | 2013 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162550 | Medtronic Model 5392 External Pulse Generator (EPG) | 2016 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 17, 2015 | Class II | Z-1356-2015 | Device Design | Possible performance issue when used with specific AA-sized (LR6) batteries. The negative terminal of a commercially available AA (LR6) battery did not maintain a sufficient connection with the battery drawer electrical contact. This… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DTE devicesDTE Pulse-Generator, Pacemaker, External: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150246 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150246: 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/K150246
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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