510(k) · Cleared
ClearedEcvue Mapping System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardioinsight Technologies, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Nov 19, 2014 as substantially equivalent to K113811 (C.R. Bard Inc., Bard Electrophysiology Division, 2012) after a 265-day review. Its family tree reaches back 6 generations to 2000. 8 later devices descend from it.
- Decided
- Nov 19, 2014
- Review
- 265 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K000248 (2000). 13 ancestors in all, the oldest K874441 (1988). 8 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 5 generations backK013083 Carto XP EP Navigation SystemBiosense Webster, Inc. · 2001
- 4 generations backK020863 Carto XP and Qwikmap EP Navigation SystemBiosense Webster, Inc. · 2003
- 3 generations backK042999 Carto XP EP Navigation System, Software Verison 8Biosense Webster, Inc. · 2005
- 2 generations backK101331 Labsystem Pro EP Recording System V3.1 SoftwareC.R. Bard Inc., Bard Electrophysiology Division · 2010
- 1 generation backK113811 V2.6 Software for the Labsystem Pro EP Recording SystemC.R. Bard Inc., Bard Electrophysiology Division · 2012
- This deviceK140497 Ecvue Mapping SystemCardioinsight Technologies, Inc. · 2014
- Descendant · cites it directly · 7 of its ownK150990 ECVUE Mapping SystemCardioinsight Technologies, Inc. · 2015
- Descendant · 2 generations on · 6 of its ownK162440 CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK181918 CardioInsight Cardiac Mapping SystemMedtronic, Inc. · 2018
- Descendant · 4 generations on · 1 of its ownK211546 Vektor Computational ECG Mapping System (vMap)Vektor Medical, Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK183195 VIVOCatheter Precision, Inc. · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K150990ECVUE Mapping SystemCardioinsight Technologies, Inc. · 2015 · cites it directly7descendants
- K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc. · 2016 · 2 generations on6descendants
- K181918CardioInsight Cardiac Mapping SystemMedtronic, Inc. · 2018 · 3 generations on2descendants
- K211546Vektor Computational ECG Mapping System (vMap)Vektor Medical, Inc. · 2021 · 4 generations on1descendant
- K183195VIVOCatheter Precision, Inc. · 2019 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000248 | Carto EP Navigation System | Biosense Webster, Inc. | 2000 | — |
| −5 | K013083 | Carto XP EP Navigation System | Biosense Webster, Inc. | 2001 | — |
| −4 | K020863 | Carto XP and Qwikmap EP Navigation System | Biosense Webster, Inc. | 2003 | — |
| −3 | K042999 | Carto XP EP Navigation System, Software Verison 8 | Biosense Webster, Inc. | 2005 | — |
| −2 | 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 | — |
| 0 (this device) | K140497 | Ecvue Mapping System | Cardioinsight Technologies, Inc. | 2014 | — |
| +1 | K150990 | ECVUE Mapping System | Cardioinsight Technologies, Inc. | 2015 | — |
| +2 | K162440 | CardioInsight Cardiac Mapping System | Cardioinsight Technologies, Inc. | 2016 | — |
| +3 | K181918 | CardioInsight Cardiac Mapping System | Medtronic, Inc. | 2018 | — |
| +4 | K211546 | Vektor Computational ECG Mapping System (vMap) | Vektor Medical, Inc. | 2021 | — |
| +3 | K183195 | VIVO | Catheter Precision, Inc. | 2019 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K113811 | V2.6 Software for the Labsystem Pro EP Recording SystemSummary page 4…425, DQK Predicate Device(s): The legally marketed device to which we are claiming equivalence is Bard LabSystem PRO EP Recording System (K113811) Summary ECVUE is a non-invasive mapping system for beat-by-beat, multi- chamber, 3D… | 2012 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150990 | ECVUE Mapping System | 2015 | 7 |
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 14 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K150990 (Cardioinsight Technologies, Inc., 2015) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K113811.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 CardioInsight ECVUE Mapping System is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140497 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140497: Ecvue Mapping System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140497
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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