# K183266: EP-TRACER System

- Pathway: 510(k) (Special)
- Applicant: Schwarzer Cardiotek GmbH
- Decided: Mar 1, 2019 after 98 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: 6 generations back to K862740 (1986). 12 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K161245: EP-TRACER System, Cardio Tek, BV (2016) Summary page 4.

## Most influential descendants
- 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 25, 2022 · Class II · Z-1283-2022: Device did not pass electrical safety testing for adequate insulation.

## Indications for use
The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, 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/K183266
Methodology: https://510kreport.com/methodology