510(k) · Cleared
ClearedAutoMark Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · DQK Computer, Diagnostic, Programmable
Cleared on Dec 13, 2016 as substantially equivalent to K141050 (St Jude Medical, 2014) and 1 other predicate after a 319-day review. Its family tree reaches back 8 generations to 2000. 28 later devices descend from it.
- Decided
- Dec 13, 2016
- Review
- 319 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K000248 (2000). 20 ancestors in all, the oldest K954395 (1995). 28 later devices descend from it, 1 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 backK063277 MapmateEp Medsystems, Inc. · 2006
- 3 generations backK092810 EP-Workmate System, Version 4.2St Jude Medical · 2009
- 2 generations backK132073 EP-Workmate, EP-Nursemate, EP-Nursemate with Physio ModuleSt Jude Medical · 2013
- 1 generation backK151911 WorkMate Claris System, WorkMate Claris System Display PlusSt Jude Medical · 2015
- This deviceK160218 AutoMark ModuleSt Jude Medical · 2016
- Descendant · cites it directly · 27 of its ownK172396 EnSite Velocity Cardiac Mapping System v5.2St Jude Medical · 2018
- Descendant · 2 generations on · 26 of its ownK182644 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- Descendant · 3 generations on · 25 of its ownK183128 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- Descendant · 4 generations on · 18 of its ownK201181 EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac…Abbott Medical · 2020
- Descendant · 5 generations on · 17 of its ownK202066 EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor…Abbott Medical · 2020
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K172396EnSite Velocity Cardiac Mapping System v5.2St Jude Medical · 2018 · cites it directly27descendants
- K182644EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2Abbott · 2018 · 2 generations on26descendants
- K183128EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2Abbott · 2018 · 3 generations on25descendants
- K201181EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping SystemAbbott Medical · 2020 · 4 generations on18descendants
- K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL…Abbott Medical · 2020 · 5 generations on17descendants
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 | K063277 | Mapmate | Ep Medsystems, Inc. | 2006 | — |
| −3 | K092810 | EP-Workmate System, Version 4.2 | St Jude Medical | 2009 | — |
| −2 | K132073 | EP-Workmate, EP-Nursemate, EP-Nursemate with Physio Module | St Jude Medical | 2013 | — |
| −1 | K151911 | WorkMate Claris System, WorkMate Claris System Display Plus | St Jude Medical | 2015 | — |
| 0 (this device) | K160218 | AutoMark Module | St Jude Medical | 2016 | — |
| +1 | 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 | — |
| +3 | K183128 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping… | Abbott | 2018 | — |
| +4 | K201181 | EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System | Abbott Medical | 2020 | — |
| +5 | K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled… | Abbott Medical | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 8 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K141050 | Ensite Velocity SystemSummary page 4…II Classification Name 870.1425, computer, diagnostic, programmable Product Code DQK Predicate Device EnSite™ Velocity™ Cardiac Mapping System (K141050) Secondary Predicates WorkMate Claris™ System (K151911) Reference Devices EnSite™ Velocity™ Cardiac Mapping System v5.0.1… | 2014 |
| * | K151911 | WorkMate Claris System, WorkMate Claris System Display PlusSummary page 4…nostic, programmable Product Code DQK Predicate Device EnSite™ Velocity™ Cardiac Mapping System (K141050) Secondary Predicates WorkMate Claris™ System (K151911) Reference Devices EnSite™ Velocity™ Cardiac Mapping System v5.0.1 with AutoMap Module v1.0.1 (K16018… | 2015 |
| † | K160187 | Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 | 2016 |
| † | K160210 | EnSite Precision Cardiac Mapping System v2.0 | 2016 |
What descends from it? (28)
See all 281 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172396 | EnSite Velocity Cardiac Mapping System v5.2 | 2018 | 27 |
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 2.1 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K172396 (St Jude Medical, 2018) has gone furthest, with 27 descendants of its own.
- 3 other devices also cite its predicate K141050.
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 EnSite™ Velocity™ Cardiac Mapping System is a suggested Diagnostic tool in patients for whom electrophysiology studies are indicated. When used with 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 system alone. OR When used with the EnSite™ Velocity™ Surface Electrode Kit, the EnSite™…
Read the full statement (113 words)
The EnSite™ Velocity™ Cardiac Mapping System is a suggested Diagnostic tool in patients for whom electrophysiology studies are indicated.
When used with 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 system alone.
OR
When used with the 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
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/K160218 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160218: AutoMark Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160218
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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