# K134044: EP-Tracer System, EP-Tracer System, EP-Tracer System

- Pathway: 510(k) (Traditional)
- Applicant: Cardio Tek, BV
- Decided: Mar 31, 2014 after 90 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K862740 (1986). 10 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071348: Ems-XL Cardiac Electrophysiology System, Mennen Medical, Ltd. (2007) Summary page 1.

## Most influential descendants
- 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
- K253088: OneStim-DUO Cardiac Stimulator (MP5003-4CO) (2026), 0 descendants of its own
- K223787: ECGenius System (2023), 0 descendants of its own

## Recalls of this device
- Apr 13, 2017 · Class II · Z-2657-2017: Software bug which allows parameters to be changed unintentionally during use.

## Indications for use
The Er-Tracer System is an electrophysiology measurement system used to acquire, filter, digitize, amplf, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart

Source page: https://510kreport.com/device/K134044
Methodology: https://510kreport.com/methodology