# K821791: External Pulse Generator - EV4542

- Pathway: 510(k) (Traditional)
- Applicant: American Pacemaker Corp.
- Decided: Jul 6, 1982 after 19 days
- Product code: DTE (Pulse-Generator, Pacemaker, External)
- Device class: 2
- Regulation: 21 CFR 870.3600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K970347: MPC (Model 7000) External Temporary Pacemaker System (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K821791
Methodology: https://510kreport.com/methodology