# K031000: Labsystem Iii EP Laboratory W/Windows Platform & Windows EP Software Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jun 3, 2003 after 64 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: 1 generation back to K874441 (1988). 3 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883152: EP-Stat, Coherent Systems, Inc. (1988) Summary page 1.
- K874441: Bard Biopotential Amplifier, C.R. Bard, Inc. (1988) Summary page 1.
- K901358: Bard Biopotential Amplifier II, C.R. Bard, Inc. (1990) Summary page 1.

## Cited in the summary but kept off the family tree
- K953267: High Level Input Isolation Module. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K101331: Labsystem Pro EP Recording System V3.1 Software (2010), 13 descendants of its own
- 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

## Indications for use
The Bard Labsystem Ill* 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. The Bard STAMP Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the Bard LabSystem [Ill]* EP Laboratory) that can record and display the information.

Source page: https://510kreport.com/device/K031000
Methodology: https://510kreport.com/methodology