510(k) · Cleared
ClearedLabsystem Pro EP Recording System V3.1 Software
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 Oct 8, 2010 as substantially equivalent to K031000 (C.R. Bard, Inc., 2003) and 1 other predicate after a 150-day review. Its family tree reaches back 4 generations to 2000. 13 later devices descend from it.
- Decided
- Oct 8, 2010
- Review
- 150 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K000248 (2000). 8 ancestors in all, the oldest K874441 (1988). 13 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 3 generations backK013083 Carto XP EP Navigation SystemBiosense Webster, Inc. · 2001
- 2 generations backK020863 Carto XP and Qwikmap EP Navigation SystemBiosense Webster, Inc. · 2003
- 1 generation backK042999 Carto XP EP Navigation System, Software Verison 8Biosense Webster, Inc. · 2005
- This deviceK101331 Labsystem Pro EP Recording System V3.1 SoftwareC.R. Bard Inc., Bard Electrophysiology Division · 2010
- Descendant · cites it directly · 12 of its ownK113811 V2.6 Software for the Labsystem Pro EP Recording SystemC.R. Bard Inc., Bard Electrophysiology Division · 2012
- Descendant · 2 generations on · 8 of its ownK140497 Ecvue Mapping SystemCardioinsight Technologies, Inc. · 2014
- Descendant · 3 generations on · 7 of its ownK150990 ECVUE Mapping SystemCardioinsight Technologies, Inc. · 2015
- Descendant · 4 generations on · 6 of its ownK162440 CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc. · 2016
- Descendant · 5 generations on · 2 of its ownK181918 CardioInsight Cardiac Mapping SystemMedtronic, Inc. · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K113811V2.6 Software for the Labsystem Pro EP Recording SystemC.R. Bard Inc., Bard Electrophysiology Division · 2012 · cites it directly12descendants
- K140497Ecvue Mapping SystemCardioinsight Technologies, Inc. · 2014 · 2 generations on8descendants
- K150990ECVUE Mapping SystemCardioinsight Technologies, Inc. · 2015 · 3 generations on7descendants
- K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc. · 2016 · 4 generations on6descendants
- K181918CardioInsight Cardiac Mapping SystemMedtronic, Inc. · 2018 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000248 | Carto EP Navigation System | Biosense Webster, Inc. | 2000 | — |
| −3 | K013083 | Carto XP EP Navigation System | Biosense Webster, Inc. | 2001 | — |
| −2 | K020863 | Carto XP and Qwikmap EP Navigation System | Biosense Webster, Inc. | 2003 | — |
| −1 | K042999 | Carto XP EP Navigation System, Software Verison 8 | Biosense Webster, Inc. | 2005 | — |
| 0 (this device) | K101331 | Labsystem Pro EP Recording System V3.1 Software | C.R. Bard Inc., Bard Electrophysiology Division | 2010 | — |
| +1 | K113811 | V2.6 Software for the Labsystem Pro EP Recording System | C.R. Bard Inc., Bard Electrophysiology Division | 2012 | — |
| +2 | K140497 | Ecvue Mapping System | Cardioinsight Technologies, Inc. | 2014 | — |
| +3 | K150990 | ECVUE Mapping System | Cardioinsight Technologies, Inc. | 2015 | — |
| +4 | K162440 | CardioInsight Cardiac Mapping System | Cardioinsight Technologies, Inc. | 2016 | — |
| +5 | K181918 | CardioInsight Cardiac Mapping System | Medtronic, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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 26.7 · 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? (2)
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…Diagnostic Computer Classification Name: Programmable Diagnostic Computer Predicate Device(s): Bard LabSystem PRO EP Recording System (K031000/June 3, 2003) 510(k) Submission for V3.1 software for the Bard… | 2003 |
| * | K042999 | Carto XP EP Navigation System, Software Verison 8Summary page 2…K0u133 1 &/3 Biosense Webster, Inc. CartoMerge Module of the CartoTM XP V8 EP Navigation System (K042999/March 21, 2005) Device Description: The LabSystem EP Recording System is a microprocessor based data acquisition system that i… | 2005 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113811 | V2.6 Software for the Labsystem Pro EP Recording System | 2012 | 12 |
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 10 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K113811 (C.R. Bard Inc., Bard Electrophysiology Division, 2012) has gone furthest, with 12 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. 2010, 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?
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…
Read the full statement (107 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101331 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101331: Labsystem Pro EP Recording System V3.1 Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101331
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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