510(k) · Cleared
ClearedEnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)
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 Sep 4, 2025 as substantially equivalent to K242016 (Abbott Medical, 2024) after a 115-day review. Its family tree reaches back 20 generations to 2000.
- Decided
- Sep 4, 2025
- Review
- 115 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K000248 (2000). 60 ancestors in all, the oldest K954395 (1995). No later device cites it as a predicate yet.
- Root · 20 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 16 generations between
- 3 generations backK223094 EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™…Abbott Medical · 2022
- 2 generations backK231415 EnSite™ X EP SystemAbbott Medical · 2023
- 1 generation backK242016 EnSite™ X EP SystemAbbott Medical · 2024
- This deviceK251463 EnSite™ X EP System, AutoMark Index Software License…Abbott Medical · 2025
Show all 20 generations
- Root · 20 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 19 generations backK013083 Carto XP EP Navigation SystemBiosense Webster, Inc. · 2001
- 18 generations backK020863 Carto XP and Qwikmap EP Navigation SystemBiosense Webster, Inc. · 2003
- 17 generations backK042999 Carto XP EP Navigation System, Software Verison 8Biosense Webster, Inc. · 2005
- 16 generations backK063277 MapmateEp Medsystems, Inc. · 2006
- 15 generations backK092810 EP-Workmate System, Version 4.2St Jude Medical · 2009
- 14 generations backK132073 EP-Workmate, EP-Nursemate, EP-Nursemate with Physio ModuleSt Jude Medical · 2013
- 13 generations backK151911 WorkMate Claris System, WorkMate Claris System Display PlusSt Jude Medical · 2015
- 12 generations backK160218 AutoMark ModuleSt Jude Medical · 2016
- 11 generations backK172396 EnSite Velocity Cardiac Mapping System v5.2St Jude Medical · 2018
- 10 generations backK182644 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- 9 generations backK183128 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- 8 generations backK201181 EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac…Abbott Medical · 2020
- 7 generations backK202066 EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor…Abbott Medical · 2020
- 6 generations backK212061 EnSite X EP SystemAbbott · 2021
- 5 generations backK213364 EnSite X EP SystemAbbott Medical · 2021
- 4 generations backK221213 EnSite X EP SystemAbbott · 2022
- 3 generations backK223094 EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™…Abbott Medical · 2022
- 2 generations backK231415 EnSite™ X EP SystemAbbott Medical · 2023
- 1 generation backK242016 EnSite™ X EP SystemAbbott Medical · 2024
- This deviceK251463 EnSite™ X EP System, AutoMark Index Software License…Abbott Medical · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K000248 | Carto EP Navigation System | Biosense Webster, Inc. | 2000 | — |
| −19 | K013083 | Carto XP EP Navigation System | Biosense Webster, Inc. | 2001 | — |
| −18 | K020863 | Carto XP and Qwikmap EP Navigation System | Biosense Webster, Inc. | 2003 | — |
| −17 | K042999 | Carto XP EP Navigation System, Software Verison 8 | Biosense Webster, Inc. | 2005 | — |
| −16 | K063277 | Mapmate | Ep Medsystems, Inc. | 2006 | — |
| −15 | K092810 | EP-Workmate System, Version 4.2 | St Jude Medical | 2009 | — |
| −14 | K132073 | EP-Workmate, EP-Nursemate, EP-Nursemate with Physio Module | St Jude Medical | 2013 | — |
| −13 | K151911 | WorkMate Claris System, WorkMate Claris System Display Plus | St Jude Medical | 2015 | — |
| −12 | K160218 | AutoMark Module | St Jude Medical | 2016 | — |
| −11 | K172396 | EnSite Velocity Cardiac Mapping System v5.2 | St Jude Medical | 2018 | — |
| −10 | K182644 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping… | Abbott | 2018 | — |
| −9 | K183128 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping… | Abbott | 2018 | — |
| −8 | K201181 | EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System | Abbott Medical | 2020 | — |
| −7 | K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled… | Abbott Medical | 2020 | — |
| −6 | K212061 | EnSite X EP System | Abbott | 2021 | — |
| −5 | K213364 | EnSite X EP System | Abbott Medical | 2021 | — |
| −4 | K221213 | EnSite X EP System | Abbott | 2022 | — |
| −3 | K223094 | EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software… | Abbott Medical | 2022 | — |
| −2 | K231415 | EnSite™ X EP System | Abbott Medical | 2023 | — |
| −1 | K242016 | EnSite™ X EP System | Abbott Medical | 2024 | — |
| 0 (this device) | K251463 | EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™… | Abbott Medical | 2025 | — |
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 |
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 |
|---|---|---|---|
| * | K242016 | EnSite™ X EP SystemSummary page 5…II Classification Name 870.1425, computer, diagnostic, programmable Product Code DQK Predicate Device EnSite™ X EP System (K242016) Device Description The EnSite™ X EP System is a catheter navigation and mapping system. A… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 9 of the 60 ancestors have a recall of any class.
- 3 other devices also cite its predicate K242016.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 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 procedures.
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.
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/K251463 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251463: EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251463
Report an extraction error
Are you the manufacturer?
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