510(k) · Cleared
ClearedEnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · DQK Computer, Diagnostic, Programmable
Cleared on Nov 25, 2020 as substantially equivalent to K201181 (Abbott Medical, 2020) and 3 other predicates after a 121-day review. Its family tree reaches back 13 generations to 2000. 17 later devices descend from it.
- Decided
- Nov 25, 2020
- Review
- 121 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K000248 (2000). 53 ancestors in all, the oldest K954395 (1995). 17 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 9 generations between
- 3 generations backK182644 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- 2 generations backK183128 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- 1 generation backK201181 EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac…Abbott Medical · 2020
- This deviceK202066 EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor…Abbott Medical · 2020
- Descendant · cites it directly · 13 of its ownK212061 EnSite X EP SystemAbbott · 2021
- Descendant · 2 generations on · 12 of its ownK213364 EnSite X EP SystemAbbott Medical · 2021
- Descendant · 3 generations on · 11 of its ownK221213 EnSite X EP SystemAbbott · 2022
- Descendant · 4 generations on · 10 of its ownK223094 EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™…Abbott Medical · 2022
- Descendant · 5 generations on · 9 of its ownK231415 EnSite™ X EP SystemAbbott Medical · 2023
Show all 13 generations
- Root · 13 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 12 generations backK013083 Carto XP EP Navigation SystemBiosense Webster, Inc. · 2001
- 11 generations backK020863 Carto XP and Qwikmap EP Navigation SystemBiosense Webster, Inc. · 2003
- 10 generations backK042999 Carto XP EP Navigation System, Software Verison 8Biosense Webster, Inc. · 2005
- 9 generations backK063277 MapmateEp Medsystems, Inc. · 2006
- 8 generations backK092810 EP-Workmate System, Version 4.2St Jude Medical · 2009
- 7 generations backK132073 EP-Workmate, EP-Nursemate, EP-Nursemate with Physio ModuleSt Jude Medical · 2013
- 6 generations backK151911 WorkMate Claris System, WorkMate Claris System Display PlusSt Jude Medical · 2015
- 5 generations backK160218 AutoMark ModuleSt Jude Medical · 2016
- 4 generations backK172396 EnSite Velocity Cardiac Mapping System v5.2St Jude Medical · 2018
- 3 generations backK182644 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- 2 generations backK183128 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- 1 generation backK201181 EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac…Abbott Medical · 2020
- This deviceK202066 EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor…Abbott Medical · 2020
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K212061EnSite X EP SystemAbbott · 2021 · cites it directly13descendants
- K213364EnSite X EP SystemAbbott Medical · 2021 · 2 generations on12descendants
- K221213EnSite X EP SystemAbbott · 2022 · 3 generations on11descendants
- K223094EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade…Abbott Medical · 2022 · 4 generations on10descendants
- K231415EnSite™ X EP SystemAbbott Medical · 2023 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K000248 | Carto EP Navigation System | Biosense Webster, Inc. | 2000 | — |
| −12 | K013083 | Carto XP EP Navigation System | Biosense Webster, Inc. | 2001 | — |
| −11 | K020863 | Carto XP and Qwikmap EP Navigation System | Biosense Webster, Inc. | 2003 | — |
| −10 | K042999 | Carto XP EP Navigation System, Software Verison 8 | Biosense Webster, Inc. | 2005 | — |
| −9 | K063277 | Mapmate | Ep Medsystems, Inc. | 2006 | — |
| −8 | K092810 | EP-Workmate System, Version 4.2 | St Jude Medical | 2009 | — |
| −7 | K132073 | EP-Workmate, EP-Nursemate, EP-Nursemate with Physio Module | St Jude Medical | 2013 | — |
| −6 | K151911 | WorkMate Claris System, WorkMate Claris System Display Plus | St Jude Medical | 2015 | — |
| −5 | K160218 | AutoMark Module | St Jude Medical | 2016 | — |
| −4 | K172396 | EnSite Velocity Cardiac Mapping System v5.2 | St Jude Medical | 2018 | — |
| −3 | K182644 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping… | Abbott | 2018 | — |
| −2 | K183128 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping… | Abbott | 2018 | — |
| −1 | K201181 | EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System | Abbott Medical | 2020 | — |
| 0 (this device) | K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled… | Abbott Medical | 2020 | — |
| +1 | K212061 | EnSite X EP System | Abbott | 2021 | — |
| +2 | K213364 | EnSite X EP System | Abbott Medical | 2021 | — |
| +3 | K221213 | EnSite X EP System | Abbott | 2022 | — |
| +4 | K223094 | EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software… | Abbott Medical | 2022 | — |
| +5 | K231415 | EnSite™ X EP System | Abbott Medical | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 6 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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? (4)
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 |
|---|---|---|---|
| * | K201181 | EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping SystemSummary page 5…oduct Code DQK Predicate Device EnSite™ Velocity Cardiac Mapping System v5.2 and EnSite Precision™ Cardiac Mapping System v2.2 (K201181) Reference Device Carto 3 EP Navigation System (K180238) Device Description The EnSite™ X EP System is a catheter nav… | 2020 |
| * | K192037 | Advisor VL Circular Mapping Catheter, Sensor EnabledSummary page 6…1220, Electrode recording catheter or electrode recording probe Product Code DRF Predicate Device Advisor™ VL Circular Mapping Catheter, Sensor Enabled™ (K192037) Device Description Advisor™ VL Circular Mapping Catheter, Sensor Enabled™ (Advisor VL) is a variable… | 2019 |
| * | K160335 | Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12…Summary page 7…20, Electrode recording catheter or electrode recording probe Product Code DRF Predicate Device Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ (K160335) Device Description Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ (Advisor FL, SE) is a cir… | 2016 |
| * | K172393 | Advisor HD Grid Mapping Catheter, Sensor EnabledSummary page 7…ode recording catheter or electrode recording probe Product Code DRF & MTD Predicate Device Advisor™ HD High Density Mapping Catheter, Sensor Enabled™ (K172393) Device Description The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is a sterile, single use… | 2018 |
| † | K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT | 2018 |
What descends from it? (17)
See all 172 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 20 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 9 of the 53 ancestors have a recall of any class.
- Of its descendants, K212061 (Abbott, 2021) has gone furthest, with 13 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. 2020, 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?
EnSite™ X EP System: The EnSite™ X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. The EnSite™ X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures. EnSite™ X EP System Contact Force Software License: When used with the TactiSys™ Quartz Equipment, the EnSite™ X EP System Contact Force…
Read the full statement (265 words)
EnSite™ X EP System:
The EnSite™ X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.
The EnSite™ X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures.
EnSite™ X EP System Contact Force Software License:
When used with the TactiSys™ Quartz Equipment, the EnSite™ X EP System Contact Force Module is intended to provide visualization of force information from compatible catheters.
EnSite™ X EP System Surface Electrode Kit:
The EnSite™ X EP Surface Electrode Kit is indicated for use with the EnSite™ X EP System in accordance with the EnSite™ X EP System indications for use.
Advisor™ VL Circular Mapping Catheter, Sensor Enabled™:
Advisor™ VL Circular Mapping Catheter, Sensor Enabled™ is a steerable electrophysiology catheter with integrated sensors. The catheter is used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart.
Advisor™ FL Circular Mapping Catheter, Sensor Enabled™:
The Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ is steerable electrophysiology catheter with integrated sensors. The catheter is used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart.
Advisor™ HD High Density Mapping Catheter, Sensor Enabled™:
The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202066: EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202066
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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