510(k) · Cleared
ClearedEnSite™ X EP System
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 Apr 20, 2026 as substantially equivalent to K251234 (Abbott Medical, 2025) and 1 other predicate after an 87-day review. Its family tree reaches back 21 generations to 2000. 2 later devices descend from it.
- Decided
- Apr 20, 2026
- Review
- 87 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 21 generations to K000248 (2000). 62 ancestors in all, the oldest K954395 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 21 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 17 generations between
- 3 generations backK231415 EnSite™ X EP SystemAbbott Medical · 2023
- 2 generations backK242016 EnSite™ X EP SystemAbbott Medical · 2024
- 1 generation backK251234 EnSite™ X EP SystemAbbott Medical · 2025
- This deviceK260212 EnSite™ X EP SystemAbbott Medical · 2026
- Descendant · cites it directly · 0 of its ownK261729 EnSite™ X EP SystemAbbott Medical · 2026
- Descendant · cites it directly · 0 of its ownK262006 EnSite™ X EP SystemAbbott Medical · 2026
Show all 21 generations
- Root · 21 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 20 generations backK013083 Carto XP EP Navigation SystemBiosense Webster, Inc. · 2001
- 19 generations backK020863 Carto XP and Qwikmap EP Navigation SystemBiosense Webster, Inc. · 2003
- 18 generations backK042999 Carto XP EP Navigation System, Software Verison 8Biosense Webster, Inc. · 2005
- 17 generations backK063277 MapmateEp Medsystems, Inc. · 2006
- 16 generations backK092810 EP-Workmate System, Version 4.2St Jude Medical · 2009
- 15 generations backK132073 EP-Workmate, EP-Nursemate, EP-Nursemate with Physio ModuleSt Jude Medical · 2013
- 14 generations backK151911 WorkMate Claris System, WorkMate Claris System Display PlusSt Jude Medical · 2015
- 13 generations backK160218 AutoMark ModuleSt Jude Medical · 2016
- 12 generations backK172396 EnSite Velocity Cardiac Mapping System v5.2St Jude Medical · 2018
- 11 generations backK182644 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- 10 generations backK183128 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- 9 generations backK201181 EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac…Abbott Medical · 2020
- 8 generations backK202066 EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor…Abbott Medical · 2020
- 7 generations backK212061 EnSite X EP SystemAbbott · 2021
- 6 generations backK213364 EnSite X EP SystemAbbott Medical · 2021
- 5 generations backK221213 EnSite X EP SystemAbbott · 2022
- 4 generations backK223094 EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™…Abbott Medical · 2022
- 3 generations backK231415 EnSite™ X EP SystemAbbott Medical · 2023
- 2 generations backK242016 EnSite™ X EP SystemAbbott Medical · 2024
- 1 generation backK251234 EnSite™ X EP SystemAbbott Medical · 2025
- This deviceK260212 EnSite™ X EP SystemAbbott Medical · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K000248 | Carto EP Navigation System | Biosense Webster, Inc. | 2000 | — |
| −20 | K013083 | Carto XP EP Navigation System | Biosense Webster, Inc. | 2001 | — |
| −19 | K020863 | Carto XP and Qwikmap EP Navigation System | Biosense Webster, Inc. | 2003 | — |
| −18 | K042999 | Carto XP EP Navigation System, Software Verison 8 | Biosense Webster, Inc. | 2005 | — |
| −17 | K063277 | Mapmate | Ep Medsystems, Inc. | 2006 | — |
| −16 | K092810 | EP-Workmate System, Version 4.2 | St Jude Medical | 2009 | — |
| −15 | K132073 | EP-Workmate, EP-Nursemate, EP-Nursemate with Physio Module | St Jude Medical | 2013 | — |
| −14 | K151911 | WorkMate Claris System, WorkMate Claris System Display Plus | St Jude Medical | 2015 | — |
| −13 | K160218 | AutoMark Module | St Jude Medical | 2016 | — |
| −12 | K172396 | EnSite Velocity Cardiac Mapping System v5.2 | St Jude Medical | 2018 | — |
| −11 | K182644 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping… | Abbott | 2018 | — |
| −10 | K183128 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping… | Abbott | 2018 | — |
| −9 | K201181 | EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System | Abbott Medical | 2020 | — |
| −8 | K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled… | Abbott Medical | 2020 | — |
| −7 | K212061 | EnSite X EP System | Abbott | 2021 | — |
| −6 | K213364 | EnSite X EP System | Abbott Medical | 2021 | — |
| −5 | K221213 | EnSite X EP System | Abbott | 2022 | — |
| −4 | K223094 | EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software… | Abbott Medical | 2022 | — |
| −3 | K231415 | EnSite™ X EP System | Abbott Medical | 2023 | — |
| −2 | K242016 | EnSite™ X EP System | Abbott Medical | 2024 | — |
| −1 | K251234 | EnSite™ X EP System | Abbott Medical | 2025 | — |
| 0 (this device) | K260212 | EnSite™ X EP System | Abbott Medical | 2026 | — |
| +1 | K261729 | EnSite™ X EP System | Abbott Medical | 2026 | — |
| +1 | K262006 | EnSite™ X EP System | Abbott Medical | 2026 | — |
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 |
| 2025 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K251234 | EnSite™ X EP SystemSummary page 5…II Classification Name 870.1425, computer, diagnostic, programmable Product Code DQK Predicate Device EnSite™ X EP System (K251234 and K252013) Device Description The EnSite™ X EP System is a catheter navigation and mapping system. A… | 2025 |
| * | K252013 | EnSite™ X EP SystemSummary page 5…Classification Name 870.1425, computer, diagnostic, programmable Product Code DQK Predicate Device EnSite™ X EP System (K251234 and K252013) Device Description The EnSite™ X EP System is a catheter navigation and mapping system. A… | 2025 |
What descends from it? (2)
2 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 26 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 9 of the 62 ancestors have a recall of any class.
- Of its descendants, K261729 (Abbott Medical, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K251234.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 (115 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260212 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260212: EnSite™ X EP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260212
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026