# K993414: Prucka Engineering Inc. Cardiolab EP System,Version 4.2

- Pathway: 510(k) (Traditional)
- Applicant: Prucka Engineering, Inc.
- Decided: Apr 7, 2000 after 178 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K862740 (1986). 6 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971570: Epxpress System (Timberwolf Revision) /000391, Quinton Electrophysiology Corp. (1997) Summary page 1.
- K935186: Electrophysiology Systems, Inc. EP-Easy, Electrophysiology Systems, Inc. (1995) Summary page 1.
- K954395: Carto System, Biosense, Ltd. (1995) Summary page 1.

## Most influential descendants
- 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
- K161245: EP-TRACER System (2016), 4 descendants of its own

## Indications for use
The intended use of the Prucka Engineering, Inc. CardioLab EP 4.2 System is 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 diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. Additionally, the system may acquire, amplify, display, and record data received from other medical devices typically used during these procedures, such as imaging devices and RF generators. The CardioLab EP system does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze physiological data or other data acquired during an EP procedure. It does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.

Source page: https://510kreport.com/device/K993414
Methodology: https://510kreport.com/methodology