# K935186: Electrophysiology Systems, Inc. EP-Easy

- Pathway: 510(k) (Traditional)
- Applicant: Electrophysiology Systems, Inc.
- Decided: Jan 3, 1995 after 434 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K993414: Prucka Engineering Inc. Cardiolab EP System,Version 4.2 (2000), 18 descendants of its own
- K020440: Newcor (2002), 9 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
- K101571: Xper Information Management and Flex Cardio Physiomonitoring Systems (2010), 5 descendants of its own

Source page: https://510kreport.com/device/K935186
Methodology: https://510kreport.com/methodology