510(k) · Cleared
ClearedV2.6 Software for the Labsystem Pro EP Recording System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard Inc., Bard Electrophysiology Division · DQK Computer, Diagnostic, Programmable
Cleared on Mar 16, 2012 as substantially equivalent to K031000 (C.R. Bard, Inc., 2003) and 2 other predicates after an 84-day review. Its family tree reaches back 5 generations to 2000. 12 later devices descend from it.
- Decided
- Mar 16, 2012
- Review
- 84 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K000248 (2000). 12 ancestors in all, the oldest K874441 (1988). 12 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 4 generations backK013083 Carto XP EP Navigation SystemBiosense Webster, Inc. · 2001
- 3 generations backK020863 Carto XP and Qwikmap EP Navigation SystemBiosense Webster, Inc. · 2003
- 2 generations backK042999 Carto XP EP Navigation System, Software Verison 8Biosense Webster, Inc. · 2005
- 1 generation backK101331 Labsystem Pro EP Recording System V3.1 SoftwareC.R. Bard Inc., Bard Electrophysiology Division · 2010
- This deviceK113811 V2.6 Software for the Labsystem Pro EP Recording SystemC.R. Bard Inc., Bard Electrophysiology Division · 2012
- Descendant · cites it directly · 8 of its ownK140497 Ecvue Mapping SystemCardioinsight Technologies, Inc. · 2014
- Descendant · 2 generations on · 7 of its ownK150990 ECVUE Mapping SystemCardioinsight Technologies, Inc. · 2015
- Descendant · 3 generations on · 6 of its ownK162440 CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc. · 2016
- Descendant · 4 generations on · 2 of its ownK181918 CardioInsight Cardiac Mapping SystemMedtronic, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK141185 V2.7 Software for the Labsystem Pro EP Recording SystemBoston Scientific Corp · 2014
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K140497Ecvue Mapping SystemCardioinsight Technologies, Inc. · 2014 · cites it directly8descendants
- K150990ECVUE Mapping SystemCardioinsight Technologies, Inc. · 2015 · 2 generations on7descendants
- K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc. · 2016 · 3 generations on6descendants
- K181918CardioInsight Cardiac Mapping SystemMedtronic, Inc. · 2018 · 4 generations on2descendants
- K141185V2.7 Software for the Labsystem Pro EP Recording SystemBoston Scientific Corp · 2014 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000248 | Carto EP Navigation System | Biosense Webster, Inc. | 2000 | — |
| −4 | K013083 | Carto XP EP Navigation System | Biosense Webster, Inc. | 2001 | — |
| −3 | K020863 | Carto XP and Qwikmap EP Navigation System | Biosense Webster, Inc. | 2003 | — |
| −2 | K042999 | Carto XP EP Navigation System, Software Verison 8 | Biosense Webster, Inc. | 2005 | — |
| −1 | K101331 | Labsystem Pro EP Recording System V3.1 Software | C.R. Bard Inc., Bard Electrophysiology Division | 2010 | — |
| 0 (this device) | K113811 | V2.6 Software for the Labsystem Pro EP Recording System | C.R. Bard Inc., Bard Electrophysiology Division | 2012 | — |
| +1 | K140497 | Ecvue Mapping System | Cardioinsight Technologies, Inc. | 2014 | — |
| +2 | K150990 | ECVUE Mapping System | Cardioinsight Technologies, Inc. | 2015 | — |
| +3 | K162440 | CardioInsight Cardiac Mapping System | Cardioinsight Technologies, Inc. | 2016 | — |
| +4 | K181918 | CardioInsight Cardiac Mapping System | Medtronic, Inc. | 2018 | — |
| +1 | K141185 | V2.7 Software for the Labsystem Pro EP Recording System | Boston Scientific Corp | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031000 | Labsystem Iii EP Laboratory W/Windows Platform & Windows EP Software Version 1.0Summary page 1…ard.com December 22, 2011 LabSystem™ PRO EP Recording System Programmable Diagnostic Computer Programmable Dia{gnostic Computer Bard LabSystem PRO EP Recording System (K031000/June 3, 2003) MAR 16 2012 510(k) Submission for V2.6 software for the Bard LABSYSTEM™ PRO EP Recording System K… | 2003 |
| * | K101331 | Labsystem Pro EP Recording System V3.1 SoftwareSummary page 2…10(k) Submission for V2.6 software for the Bard LABSYSTEM™ PRO EP Recording System K138t 3 V3.1 Software for the Bard LabSystem PRO EP Recording System (K101331/October 8, 2010) GE Medical Systems Information Technologies, MAC- LAB/CARDIOLAB EP/COMBOLAB System (K032577/October 10, 2003)… | 2010 |
| * | K032577 | Modification to: Mac-Lab/Cardiolab EP/Combolab SystemSummary page 2….1 Software for the Bard LabSystem PRO EP Recording System (K101331/October 8, 2010) GE Medical Systems Information Technologies, MAC- LAB/CARDIOLAB EP/COMBOLAB System (K032577/October 10, 2003) Device Description: The V2.6 software for the LabSystem™ PRO EP Recording System is a bidirectional software… | 2003 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K140497 (Cardioinsight Technologies, Inc., 2014) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K031000.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
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…
Read the full statement (155 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K113811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113811: V2.6 Software for the Labsystem Pro EP Recording System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113811
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026