510(k) · Cleared
Recalled · Class II · 2015Medtronic 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 Oct 31, 2013 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it. It has been recalled once.
- Decided
- Oct 31, 2013
- Review
- 43 days
- Class
- Class II
- Product code
- DTE
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK132924 Medtronic External Pulse Generator (Epg)Medtronic, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK150246 Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 3 of its ownK162550 Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK181973 Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2018
- Descendant · 4 generations on · 1 of its ownK190825 Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK162054 Medtronic Temporary External Pacemaker 53401Medtronic, Inc. · 2016 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K150246Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2015 · cites it directly4descendants
- K162550Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2016 · 2 generations on3descendants
- K181973Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2018 · 3 generations on2descendants
- K190825Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2019 · 4 generations on1descendant
- K162054Medtronic Temporary External Pacemaker 53401Medtronic, Inc. · 2016 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K132924 | Medtronic External Pulse Generator (Epg) | Medtronic, Inc. | 2013 | — |
| +1 | K150246 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2015 | 1 |
| +2 | K162550 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2016 | — |
| +3 | K181973 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2018 | — |
| +4 | K190825 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2019 | — |
| +1 | K162054 | Medtronic Temporary External Pacemaker 53401 | Medtronic, Inc. | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K150246 (Medtronic, Inc., 2015) has gone furthest, with 4 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. 2013, 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 | — |
https://510kreport.com/device/K132924 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132924: Medtronic 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/K132924
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026