# K101331: Labsystem Pro EP Recording System V3.1 Software

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard Inc., Bard Electrophysiology Division
- Decided: Oct 8, 2010 after 150 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: 4 generations back to K000248 (2000). 8 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031000: Labsystem Iii EP Laboratory W/Windows Platform & Windows EP Software Version 1.0, C.R. Bard, Inc. (2003) Summary page 1.
- K042999: Carto XP EP Navigation System, Software Verison 8, Biosense Webster, Inc. (2005) Summary page 2.

## Most influential descendants
- K113811: V2.6 Software for the Labsystem Pro EP Recording System (2012), 12 descendants of its own
- K140497: Ecvue Mapping System (2014), 8 descendants of its own
- K150990: ECVUE Mapping System (2015), 7 descendants of its own
- K162440: CardioInsight Cardiac Mapping System (2016), 6 descendants of its own
- K181918: CardioInsight Cardiac Mapping System (2018), 2 descendants of its own

## Indications for use
The Bard LabSystem EP Laboratory is a computer and software driven data acquisition and analysis tool designed to facilitate the gathering, display, analysis by a physician, pace mapping and storage of cardiac electrophysiologic data. When integrated with the Philips EP navigator system, the BARD® LabSystem PRO EP Recording System is designed to acquire, analyze, and display 3D electro-anatomical maps of the human heart. The maps are constructed using intracardiac electrograms with their respective cardiac locations taken from live x-ray overlay on a patient's 3D cardiac anatomy. Maps may be displayed as electrical activation maps, voltage maps, dominant frequency maps and location maps with user defined measurement values.

Source page: https://510kreport.com/device/K101331
Methodology: https://510kreport.com/methodology