510(k) · Cleared
ClearedCardioInsight Cardiac 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 4, 2016 as substantially equivalent to K150990 (Cardioinsight Technologies, Inc., 2015) after a 65-day review. Its family tree reaches back 8 generations to 2000. 6 later devices descend from it.
- Decided
- Nov 4, 2016
- Review
- 65 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K000248 (2000). 15 ancestors in all, the oldest K874441 (1988). 6 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 7 generations backK013083 Carto XP EP Navigation SystemBiosense Webster, Inc. · 2001
- 6 generations backK020863 Carto XP and Qwikmap EP Navigation SystemBiosense Webster, Inc. · 2003
- 5 generations backK042999 Carto XP EP Navigation System, Software Verison 8Biosense Webster, Inc. · 2005
- 4 generations backK101331 Labsystem Pro EP Recording System V3.1 SoftwareC.R. Bard Inc., Bard Electrophysiology Division · 2010
- 3 generations backK113811 V2.6 Software for the Labsystem Pro EP Recording SystemC.R. Bard Inc., Bard Electrophysiology Division · 2012
- 2 generations backK140497 Ecvue Mapping SystemCardioinsight Technologies, Inc. · 2014
- 1 generation backK150990 ECVUE Mapping SystemCardioinsight Technologies, Inc. · 2015
- This deviceK162440 CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK181918 CardioInsight Cardiac Mapping SystemMedtronic, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK211546 Vektor Computational ECG Mapping System (vMap)Vektor Medical, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK183195 VIVOCatheter Precision, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK253861 Acorys Mapping SystemCorify Care S.L · 2026
- Descendant · 3 generations on · 0 of its ownK252429 Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K181918CardioInsight Cardiac Mapping SystemMedtronic, Inc. · 2018 · cites it directly2descendants
- K211546Vektor Computational ECG Mapping System (vMap)Vektor Medical, Inc. · 2021 · 2 generations on1descendant
- K183195VIVOCatheter Precision, Inc. · 2019 · cites it directly1descendant
- K253861Acorys Mapping SystemCorify Care S.L · 2026 · cites it directly0descendants
- K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K000248 | Carto EP Navigation System | Biosense Webster, Inc. | 2000 | — |
| −7 | K013083 | Carto XP EP Navigation System | Biosense Webster, Inc. | 2001 | — |
| −6 | K020863 | Carto XP and Qwikmap EP Navigation System | Biosense Webster, Inc. | 2003 | — |
| −5 | K042999 | Carto XP EP Navigation System, Software Verison 8 | Biosense Webster, Inc. | 2005 | — |
| −4 | K101331 | Labsystem Pro EP Recording System V3.1 Software | C.R. Bard Inc., Bard Electrophysiology Division | 2010 | — |
| −3 | 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 | — |
| −1 | K150990 | ECVUE Mapping System | Cardioinsight Technologies, Inc. | 2015 | — |
| 0 (this device) | K162440 | CardioInsight Cardiac Mapping System | Cardioinsight Technologies, Inc. | 2016 | — |
| +1 | K181918 | CardioInsight Cardiac Mapping System | Medtronic, Inc. | 2018 | — |
| +2 | K211546 | Vektor Computational ECG Mapping System (vMap) | Vektor Medical, Inc. | 2021 | — |
| +1 | K183195 | VIVO | Catheter Precision, Inc. | 2019 | — |
| +1 | K253861 | Acorys Mapping System | Corify Care S.L | 2026 | — |
| +3 | K252429 | Vektor Computational ECG Mapping System (vMap®) | Vektor Medical, Inc. | 2025 | — |
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 |
|---|---|---|
| 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 26.6 · 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? (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 |
|---|---|---|---|
| * | K150990 | ECVUE Mapping SystemSummary page 4…I Panel: Cardiovascular Product Code: DQK Regulation: 21 CFR 870.1425 Predicate Device(s): ECVUE MAPPING SYSTEM, (K150990) CardioInsight™ Cardiac Mapping System Response to Questions K162440 Medtronic Confidential… | 2015 |
What descends from it? (6)
3 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 16 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K181918 (Medtronic, Inc., 2018) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Medtronic CardioInsight Cardiac 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/K162440 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162440: CardioInsight Cardiac Mapping System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162440
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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