# K011826: EPS320 Cardiac Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Micropace Pty, Ltd.
- Decided: Jan 24, 2002 after 227 days
- Product code: JOQ (Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only))
- Device class: 2
- Regulation: 21 CFR 870.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K854196 (1986). 1 ancestor in all.
11 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K854196: Dci Model EP-2 Clinical Stimulator, Digital Cardiovascular Instruments, Inc. (1986) Summary page 3.

## Most influential descendants
- K071348: Ems-XL Cardiac Electrophysiology System (2007), 7 descendants of its own
- K134044: EP-Tracer System, EP-Tracer System, EP-Tracer System (2014), 5 descendants of its own
- K161245: EP-TRACER System (2016), 4 descendants of its own
- K183266: EP-TRACER System (2019), 3 descendants of its own
- K220306: ECGenius System (2022), 1 descendant of its own

## Indications for use
The EPS320 Stimulator System is an electrical stimulus generator for diagnostic cardiac stimulation during electrophysiological testing of the human heart.

Source page: https://510kreport.com/device/K011826
Methodology: https://510kreport.com/methodology