510(k) · Cleared
ClearedEnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License
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 Jun 26, 2020 as substantially equivalent to K183128 (Abbott, 2018) after a 58-day review. Its family tree reaches back 12 generations to 2000. 5 later devices descend from it.
- Decided
- Jun 26, 2020
- Review
- 58 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K000248 (2000). 34 ancestors in all, the oldest K954395 (1995). 5 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 8 generations between
- 3 generations backK172396 EnSite Velocity Cardiac Mapping System v5.2St Jude Medical · 2018
- 2 generations backK182644 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- 1 generation backK183128 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- This deviceK201148 EnSite Precision Cardiac Mapping System v2.6, EnSite Precision…Abbott Medical · 2020
- Descendant · cites it directly · 4 of its ownK241828 Affera Integrated Mapping System; Impedance Localization Patch KitMedtronic, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK243892 Affera Integrated Mapping SystemMedtronic, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK262005 Affera Integrated Mapping SystemMedtronic, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK250747 Globe® Pulsed Field SystemKardium, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK243435 Magnetic Localization Patch Kit (AFR-00021)Medtronic, Inc. · 2024
Show all 12 generations
- Root · 12 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- 11 generations backK013083 Carto XP EP Navigation SystemBiosense Webster, Inc. · 2001
- 10 generations backK020863 Carto XP and Qwikmap EP Navigation SystemBiosense Webster, Inc. · 2003
- 9 generations backK042999 Carto XP EP Navigation System, Software Verison 8Biosense Webster, Inc. · 2005
- 8 generations backK063277 MapmateEp Medsystems, Inc. · 2006
- 7 generations backK092810 EP-Workmate System, Version 4.2St Jude Medical · 2009
- 6 generations backK132073 EP-Workmate, EP-Nursemate, EP-Nursemate with Physio ModuleSt Jude Medical · 2013
- 5 generations backK151911 WorkMate Claris System, WorkMate Claris System Display PlusSt Jude Medical · 2015
- 4 generations backK160218 AutoMark ModuleSt Jude Medical · 2016
- 3 generations backK172396 EnSite Velocity Cardiac Mapping System v5.2St Jude Medical · 2018
- 2 generations backK182644 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- 1 generation backK183128 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- This deviceK201148 EnSite Precision Cardiac Mapping System v2.6, EnSite Precision…Abbott Medical · 2020
Most influential descendants
Showing 5 of 5 · See all- K241828Affera Integrated Mapping System; Impedance Localization Patch KitMedtronic, Inc. · 2024 · cites it directly4descendants
- K243892Affera Integrated Mapping SystemMedtronic, Inc. · 2025 · 2 generations on1descendant
- K262005Affera Integrated Mapping SystemMedtronic, Inc. · 2026 · 3 generations on0descendants
- K250747Globe® Pulsed Field SystemKardium, Inc. · 2025 · 2 generations on0descendants
- K243435Magnetic Localization Patch Kit (AFR-00021)Medtronic, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K000248 | Carto EP Navigation System | Biosense Webster, Inc. | 2000 | — |
| −11 | K013083 | Carto XP EP Navigation System | Biosense Webster, Inc. | 2001 | — |
| −10 | K020863 | Carto XP and Qwikmap EP Navigation System | Biosense Webster, Inc. | 2003 | — |
| −9 | K042999 | Carto XP EP Navigation System, Software Verison 8 | Biosense Webster, Inc. | 2005 | — |
| −8 | K063277 | Mapmate | Ep Medsystems, Inc. | 2006 | — |
| −7 | K092810 | EP-Workmate System, Version 4.2 | St Jude Medical | 2009 | — |
| −6 | K132073 | EP-Workmate, EP-Nursemate, EP-Nursemate with Physio Module | St Jude Medical | 2013 | — |
| −5 | K151911 | WorkMate Claris System, WorkMate Claris System Display Plus | St Jude Medical | 2015 | — |
| −4 | K160218 | AutoMark Module | St Jude Medical | 2016 | — |
| −3 | K172396 | EnSite Velocity Cardiac Mapping System v5.2 | St Jude Medical | 2018 | — |
| −2 | K182644 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping… | Abbott | 2018 | — |
| −1 | K183128 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping… | Abbott | 2018 | — |
| 0 (this device) | K201148 | EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software… | Abbott Medical | 2020 | — |
| +1 | K241828 | Affera Integrated Mapping System; Impedance Localization Patch Kit | Medtronic, Inc. | 2024 | — |
| +2 | K243892 | Affera Integrated Mapping System | Medtronic, Inc. | 2025 | — |
| +3 | K262005 | Affera Integrated Mapping System | Medtronic, Inc. | 2026 | — |
| +2 | K250747 | Globe® Pulsed Field System | Kardium, Inc. | 2025 | — |
| +2 | K243435 | Magnetic Localization Patch Kit (AFR-00021) | Medtronic, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K183128 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2Summary page 5…ct Code DQK Predicate Device EnSite™ Velocity™ Cardiac Mapping System v5.2 and EnSite Precision™ Cardiac Mapping System v2.2 (K183128) Reference Device Not Applicable Device Description The EnSite™ Velocity™ Cardiac Mapping System v5.2 / EnSite Prec… | 2018 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241828 | Affera Integrated Mapping System; Impedance Localization Patch Kit | 2024 | 4 |
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.
- 1 of the 34 ancestors has a recall of any class.
- Of its descendants, K241828 (Medtronic, Inc., 2024) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K183128.
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™ Velocity™ Cardiac Mapping System v5.2: The EnSite™ Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. When used with the EnSite™ Array™ Catheter, the EnSite™ Velocity™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. or When used with an…
Read the full statement (420 words)
EnSite™ Velocity™ Cardiac Mapping System v5.2:
The EnSite™ Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.
When used with the EnSite™ Array™ Catheter, the EnSite™ Velocity™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
or
When used with an EnSite™ Velocity™ Surface Electrode Kit, the EnSite™ Velocity™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.
EnSite Precision™ Cardiac Mapping System v2.6:
The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.
The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™ Module to combine and display magnetic processed patient positioning and navigation mapping information.
When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
or
When used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.
EnSite™ Verismo™ Segmentation Tool:
The EnSite Verismo™ Segmentation Tool is indicated for use in generating 3D models from CT, MR or rotational angiography DICOM image data. Generated models are intended to be displayed on the EnSite Velocity System.
EnSite™ Derexi™ Module:
When used with EnSite™ Derexi ™ Module, the EnSite System interfaces to the EP-WorkMate™ System / WorkMate Claris™ System for synchronizing and display of patient information.
EnSite™ Courier™ Module:
When used with EnSite Courier Module allows the patient data to be archived to, and retrieved from, a DICOM conformant PACs server.
EnSite™ Fusion™ Registration Module:
EnSite Fusion is indicated for registering the EnSite NavX navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers.
EnSite™ Contact Force Module:
When used with the SJM Contact Force Unit, the EnSite™ Contact Force Module is intended to provide visualization of force information from compatible catheters.
EnSite™ AutoMap Module:
When used with the EnSite AutoMap Module, the EnSite System is intended to automatically collect mapping points based on criteria set by the user.
AutoMark Module:
When used with compatible hardware, the AutoMark Module is intended to automatically catalog and display various parameters associated with RF information on the 3D model in real-time.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201148: EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201148
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