# K113811: V2.6 Software for the Labsystem Pro EP Recording System

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard Inc., Bard Electrophysiology Division
- Decided: Mar 16, 2012 after 84 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: 5 generations back to K000248 (2000). 12 ancestors in all.
12 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)
- K031000: Labsystem Iii EP Laboratory W/Windows Platform & Windows EP Software Version 1.0, C.R. Bard, Inc. (2003) Summary page 1.
- K101331: Labsystem Pro EP Recording System V3.1 Software, C.R. Bard Inc., Bard Electrophysiology Division (2010) Summary page 2.
- K032577: Modification to: Mac-Lab/Cardiolab EP/Combolab System, Ge Medical Systems Information Technologies (2003) Summary page 2.

## Most influential descendants
- 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
- K141185: V2.7 Software for the Labsystem Pro EP Recording System (2014), 2 descendants of its own

## Indications for use
V2.6 software for the LabSystem™ PRO EP Recording System Indication: 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 Biosense Webster® CARTO™ 3 system, the Bard® LabSystem™ PRO EP Recording System is designed to: a) send patient demographics to Biosense Webster® CARTO™ 3, and b) acquire (from Biosense Webster® CARTO™ 3), store and display: i) synchronized 3D mapping events, ii) stimulation pacing data, and i) images of completed 3D electro-anatomical maps of the human heart. The 3D mapping events and images are created by the Biosense Webster® CARTO™ 3 device and stored on the Bard® LabSystem™ PRO EP Recording System for review and insertion into the final clinical report. Integration also supports bidirectional communication of stimulation pacing channel selection and information sharing between the two systems.

Source page: https://510kreport.com/device/K113811
Methodology: https://510kreport.com/methodology