510(k) Report

510(k) · Cleared

Cleared

Ensite Velocity System, Model EE3000

K101419510(k) SpecialCleared Jun 11, 201022-day reviewClass II21 CFR 870.1425

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

St Jude Medical · DQK Computer, Diagnostic, Programmable

Cleared on Jun 11, 2010 as substantially equivalent to K093942 (St Jude Medical, 2010) after a 22-day review. Its family tree reaches back 1 generation to 2010. 66 later devices descend from it.

Decided
Jun 11, 2010
Review
22 days
Class
Class II
Product code
DQK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K093942 (2010). 66 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2011: 1 descendant cleared2013: 2 descendants cleared2018: 5 descendants cleared2023: 5 descendants cleared2020: 6 descendants cleared2014: 1 descendant cleared2015: 1 descendant cleared2022: 6 descendants cleared2017: 1 descendant cleared2025: 14 descendants cleared2019: 2 descendants cleared2024: 9 descendants cleared2021: 4 descendants cleared2026: 8 descendants clearedK093942 · Ensite Velocity System V1.3 · St Jude Medical · 20102010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 6 descendants4 generations forward: 6 descendants5 generations forward: 6 descendants6 generations forward: 6 descendants7 generations forward: 10 descendants8 generations forward: 9 descendants9 generations forward: 7 descendants10 generations forward: 1 descendant11 generations forward: 1 descendant12 generations forward: 1 descendant13 generations forward: 4 descendants14 generations forward: 2 descendants15 generations forward: 2 descendants K093942 · Ensite Velocity System V1.3 · St Jude Medical · 20100+5+10+15
  1. Root · 1 generation backK093942 Ensite Velocity System V1.3St Jude Medical · 2010
  2. This deviceK101419 Ensite Velocity System, Model EE3000St Jude Medical · 2010
  3. Descendant · cites it directly · 36 of its ownK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
  4. Descendant · 2 generations on · 35 of its ownK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
  5. Descendant · cites it directly · 28 of its ownK160187 Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module…St Jude Medical · 2016
  6. Descendant · 2 generations on · 27 of its ownK172396 EnSite Velocity Cardiac Mapping System v5.2St Jude Medical · 2018
  7. Descendant · 3 generations on · 26 of its ownK182644 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision…Abbott · 2018

Showing 5 of 66 descendants. See all descendants

Descendants cleared per year

2011: 12013: 22014: 12015: 12016: 12017: 12018: 52019: 22020: 62021: 42022: 62023: 52024: 92025: 142026: 8
2011high 14 (2025) · low 0 (2012)2026

Most influential descendants

Showing 5 of 66 · See all
  • K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · cites it directly36descendants
  • K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH · 2013 · 2 generations on35descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K093942Ensite Velocity System V1.3St Jude Medical2010—
0 (this device)K101419Ensite Velocity System, Model EE3000St Jude Medical2010—
+1K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011—
+2K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp…Philips Medizin Systeme Boeblingen GmbH2013—
+1K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical2016—
+2K172396EnSite Velocity Cardiac Mapping System v5.2St Jude Medical2018—
+3K182644EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping…Abbott2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201320
201410
201510
201610
201710
201850
201920
202060
202140
202260
202350
202490
2025140
202680
FIG. 1 — Lineage of K101419, 2010–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K093942Ensite Velocity System V1.3
Summary page 2
…The EnSite Velocity System with EnSite Courier"" has the same intended use and fundamental scientific technology as the predicate device, EnSite Velocity System v.1.3 (K093942). All technological characteristics of the EnSite Velocity System with EnSite Courier TM are substantially equivalent to the pre…
St Jude Medical2010—

Also cleared against K093942: 2 other devices →

What descends from it? (66)

See all 66

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136
K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical201628

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?

  • Its one ancestor has no recall.
  • Of its descendants, K111905 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2011) has gone furthest, with 36 descendants of its own.
  • 2 other devices also cite its predicate K093942.

How does its category compare?

All DQK devices

DQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · DQK

23so far in 2026, the most since 2007

2007: 132008: 42009: 122010: 92011: 122012: 72013: 132014: 92015: 72016: 152017: 72018: 142019: 152020: 162021: 162022: 192023: 212024: 132025: 222026 (partial year): 23
2007high 23 (2026) · low 4 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQK

95in 2025

2007: 83 days median2008: 70 days median2009: 93 days median2010: 64 days median2011: 69 days median2012: 74 days median2013: 68 days median2014: 90 days median2015: 125 days median2016: 190 days median2017: 146 days median2018: 150 days median2019: 113 days median2020: 123 days median2021: 132 days median2022: 136 days median2023: 133 days median2024: 100 days median2025: 95 days median2026 (partial year): 151 days median
2007high 190 (2016) · low 64 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQK

1in 2025

2007: 42008: 12009: 22010: 32011: 22012: 32013: 12014: 42015: 22017: 22018: 62019: 12020: 12021: 12022: 22023: 22024: 242025: 12026 (partial year): 2
2007high 24 (2024) · low 0 (2016)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQK

433in 2025

2007: 182008: 342009: 402010: 492011: 552012: 1292013: 1802014: 1152015: 1312016: 3402017: 2522018: 2612019: 2182020: 2152021: 3512022: 3192023: 3402024: 5572025: 433
2007high 557 (2024) · low 18 (2007)2025

MAUDE reports naming product code DQK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071383418
2008470134
20091293240
2010964349
20111269255
20127743129
201313681180
20149904115
201571252131
2016151900340
201771462252
2018141506261
2019151131218
2020161231215
2021161321351
2022191362319
2023211332340
20241310024557
202522951433
2026231512—

What is it indicated for?

The EnSite Velocity TM Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.

*When used with the EnSite ArrayTM 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 (EP) catheters in the heart.

Indications for use as stated in the FDA summary.

Also cleared against K093942

2 other devices cite the same predicate.

  • K101328Ensite Velocity SystemSt Jude Medical · 2010
  • K101667Ensite Velocity System Referred to Ensite Velocity System with Positional Reference Tool (PRT)St Jude Medical · 2010

More from St Jude Medical

304 FDA decisions under this applicant name. See the company

  • P960016/S094Ampere GeneratorSt Jude Medical · 2026
  • P130026/S102TactiSys Quartz Equipment; Ampere GeneratorSt Jude Medical · 2026
  • P130026/S100TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™St Jude Medical · 2026
  • P130026/S101TactiCath™ Ablation Catheter, Sensor Enabled™ (TactiCath™ SE)St Jude Medical · 2026
  • P130026/S099TactiCath™ CF Ablation Catheter, Sensor Enabled™ (A-TCSE-D; A-TCSE-F; A-TCSE-J; A-TCSE-DD; A-TCSE-DF…St Jude Medical · 2026

Recent decisions in DQK

The DQK category page

  • K263380STAR Apollo™ Mapping SystemRhythm AI, Ltd. · 2026
  • K263016Intra-Operative Positioning System (IOPS) and IOPS Visionary SystemCenterline Biomedical · 2026
  • K261729EnSite™ X EP SystemAbbott Medical · 2026
  • K253692AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific · 2026
  • K262005Affera Integrated Mapping SystemMedtronic, Inc. · 2026

https://510kreport.com/device/K101419 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101419: Ensite Velocity System, Model EE3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101419

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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