# K132924: Medtronic External Pulse Generator (Epg)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Oct 31, 2013 after 43 days
- Product code: DTE (Pulse-Generator, Pacemaker, External)
- Device class: 2
- Regulation: 21 CFR 870.3600
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K150246: Medtronic Model 5392 External Pulse Generator (EPG) (2015), 4 descendants of its own
- K162550: Medtronic Model 5392 External Pulse Generator (EPG) (2016), 3 descendants of its own
- K181973: Medtronic Model 5392 External Pulse Generator (EPG) (2018), 2 descendants of its own
- K190825: Medtronic Model 5392 External Pulse Generator (EPG) (2019), 1 descendant of its own
- K162054: Medtronic Temporary External Pacemaker 53401 (2016), 1 descendant of its own

## Recalls of this device
- Mar 17, 2015 · Class II · Z-1356-2015: 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 batter

Source page: https://510kreport.com/device/K132924
Methodology: https://510kreport.com/methodology