# K854196: Dci Model EP-2 Clinical Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Digital Cardiovascular Instruments, Inc.
- Decided: May 1, 1986 after 198 days
- Product code: DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive))
- Device class: 2
- Regulation: 21 CFR 870.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K011826: EPS320 Cardiac Stimulator (2002), 11 descendants of its own
- 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

Source page: https://510kreport.com/device/K854196
Methodology: https://510kreport.com/methodology