# K071348: Ems-XL Cardiac Electrophysiology System

- Pathway: 510(k) (Traditional)
- Applicant: Mennen Medical, Ltd.
- Decided: Sep 7, 2007 after 116 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
Longest line of descent: 3 generations back to K862740 (1986). 9 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993414: Prucka Engineering Inc. Cardiolab EP System,Version 4.2, Prucka Engineering, Inc. (2000) Summary page 1.
- K011826: EPS320 Cardiac Stimulator, Micropace Pty, Ltd. (2002) Summary page 1.

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

## Indications for use
EMS-XL is indicated to acquire, filter, digitize, amplify, display and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals and pressure recordings. Physiological parameters such as the diastolic, systolic and mean blood pressure, heart rate and cycle length are derived from the signal data, displayed and recorded. The system allows the user to monitor, display and record the signal data. The system allows the user to monitor the acquisition data, review the data, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. The system may display and record data received from other medical devices typically used during these procedures, such as Ablation RF generators. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the human heart.

Source page: https://510kreport.com/device/K071348
Methodology: https://510kreport.com/methodology