510(k) · Cleared
ClearedEnsite Velocity System
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 May 5, 2011 as substantially equivalent to K101667 (St Jude Medical, 2010) after a 69-day review. Its family tree reaches back 2 generations to 2010. 29 later devices descend from it.
- Decided
- May 5, 2011
- Review
- 69 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K093942 (2010). 29 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK093942 Ensite Velocity System V1.3St Jude Medical · 2010
- 1 generation backK101667 Ensite Velocity System Referred to Ensite Velocity System with…St Jude Medical · 2010
- This deviceK110549 Ensite Velocity SystemSt Jude Medical · 2011
- Descendant · cites it directly · 28 of its ownK160187 Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module…St Jude Medical · 2016
- Descendant · 2 generations on · 27 of its ownK172396 EnSite Velocity Cardiac Mapping System v5.2St Jude Medical · 2018
- Descendant · 3 generations on · 26 of its ownK182644 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- Descendant · 4 generations on · 25 of its ownK183128 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018
- Descendant · 5 generations on · 18 of its ownK201181 EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac…Abbott Medical · 2020
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical · 2016 · cites it directly28descendants
- K172396EnSite Velocity Cardiac Mapping System v5.2St Jude Medical · 2018 · 2 generations on27descendants
- K182644EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2Abbott · 2018 · 3 generations on26descendants
- K183128EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2Abbott · 2018 · 4 generations on25descendants
- K201181EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping SystemAbbott Medical · 2020 · 5 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K093942 | Ensite Velocity System V1.3 | St Jude Medical | 2010 | — |
| −1 | K101667 | Ensite Velocity System Referred to Ensite Velocity System with Positional… | St Jude Medical | 2010 | — |
| 0 (this device) | K110549 | Ensite Velocity System | St Jude Medical | 2011 | — |
| +1 | K160187 | Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 | St Jude Medical | 2016 | — |
| +2 | K172396 | EnSite Velocity Cardiac Mapping System v5.2 | St Jude Medical | 2018 | — |
| +3 | K182644 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping… | Abbott | 2018 | — |
| +4 | K183128 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping… | Abbott | 2018 | — |
| +5 | K201181 | EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System | Abbott Medical | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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 26.6 · 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 |
|---|---|---|---|
| * | K101667 | Ensite Velocity System Referred to Ensite Velocity System with Positional Reference Tool…Summary page 1…dical One St. Jude Medical Drive St. Paul, MN 55117 USA The Establishment Registration Number is 2184149. 12.2 Predicate Device EnSite Velocity System with PRT (K101667). 12.3 Common or Usual Name Electrophysiology Mapping System with console and catheter 12.4 Proprietary Name EnS… | 2010 |
What descends from it? (29)
See all 291 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160187 | Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 | 2016 | 28 |
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 1 year and passes through 1 company; a new generation was cleared every 10 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K160187 (St Jude Medical, 2016) has gone furthest, with 28 descendants of its own.
- 1 other device also cites its predicate K101667.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 the EnSite Array™ Catheter, the EnSite 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 the EnSite NavX Surface Electrode Kit, the EnSite System is intended to display the position of conventional electrophysiology (ER) catheters in the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110549: Ensite Velocity System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110549
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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