510(k) · Cleared
ClearedEnSite Velocity Surface Electrode Kit
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 Oct 7, 2016 as substantially equivalent to K141050 (St Jude Medical, 2014) after a 254-day review. Its family tree reaches back 5 generations to 2010. 1 later device descends from it.
- Decided
- Oct 7, 2016
- Review
- 254 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K093942 (2010). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK093942 Ensite Velocity System V1.3St Jude Medical · 2010
- 4 generations backK101667 Ensite Velocity System Referred to Ensite Velocity System with…St Jude Medical · 2010
- 3 generations backK112688 Ensite Velocity System V.3.0St Jude Medical · 2011
- 2 generations backK130594 Ensite Velocity SystemSt Jude Medical · 2013
- 1 generation backK141050 Ensite Velocity SystemSt Jude Medical · 2014
- This deviceK160186 EnSite Velocity Surface Electrode KitSt Jude Medical · 2016
- Descendant · cites it directly · 0 of its ownK201094 iMap 3D Mapping & Navigation System (iMap System)Cardionxt, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K201094iMap 3D Mapping & Navigation System (iMap System)Cardionxt, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K093942 | Ensite Velocity System V1.3 | St Jude Medical | 2010 | — |
| −4 | K101667 | Ensite Velocity System Referred to Ensite Velocity System with Positional… | St Jude Medical | 2010 | — |
| −3 | K112688 | Ensite Velocity System V.3.0 | St Jude Medical | 2011 | — |
| −2 | K130594 | Ensite Velocity System | St Jude Medical | 2013 | — |
| −1 | K141050 | Ensite Velocity System | St Jude Medical | 2014 | — |
| 0 (this device) | K160186 | EnSite Velocity Surface Electrode Kit | St Jude Medical | 2016 | — |
| +1 | K201094 | iMap 3D Mapping & Navigation System (iMap System) | Cardionxt, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K141050 | Ensite Velocity SystemSummary page 4…Class II Predicate Device: EnSite™ Velocity™ Cardiac Mapping System (version 4.0.2) with EnSite™ NavX™ Surface Electrode Kit, K141050, cleared June 6, 2014 Device Description: The EnSite™ Velocity™ Cardiac Mapping System is a… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201094 | iMap 3D Mapping & Navigation System (iMap System) | 2021 | 0 |
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 6 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K201094 (Cardionxt, Inc., 2021) has gone furthest, with 0 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160186 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160186: EnSite Velocity Surface Electrode Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160186
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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