510(k) Report

510(k) · Cleared

Cleared

Modification to Ensite System, Model EE3000

K060954510(k) SpecialCleared Apr 21, 200614-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, Inc.-Endocardial Solutions · DQK Computer, Diagnostic, Programmable

Cleared on Apr 21, 2006 as substantially equivalent to K042493 (Endocardial Solutions, Inc., 2004) after a 14-day review. Its family tree reaches back 4 generations to 2000. 51 later devices descend from it.

Decided
Apr 21, 2006
Review
14 days
Class
Class II
Product code
DQK
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K001437 (2000). 51 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 3 descendants cleared2013: 1 descendant cleared2009: 3 descendants cleared2010: 1 descendant cleared2017: 2 descendants cleared2011: 2 descendants cleared2020: 2 descendants cleared2014: 2 descendants cleared2018: 5 descendants cleared2024: 4 descendants cleared2019: 2 descendants cleared2022: 3 descendants cleared2023: 5 descendants cleared2025: 7 descendants cleared2021: 2 descendants cleared2012: 1 descendant cleared2016: 1 descendant cleared2026: 5 descendants clearedK001437 · Ensite 3000 System, Model EE3000 · Endocardial Solutions, Inc. · 2000K012926 · Modification to Ensite 3000 System, Model EE3000 · Endocardial Solutions, Inc. · 2001K030129 · Modification to Ensite 3000 System, Model EE3000 · Endocardial Solutions, Inc. · 2003K042493 · Ensite System, Model EE3000 · Endocardial Solutions, Inc. · 2004200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 3 descendants4 generations forward: 5 descendants5 generations forward: 7 descendants6 generations forward: 3 descendants7 generations forward: 3 descendants8 generations forward: 5 descendants9 generations forward: 2 descendants10 generations forward: 1 descendant11 generations forward: 2 descendants12 generations forward: 3 descendants13 generations forward: 2 descendants14 generations forward: 5 descendants15 generations forward: 4 descendants K042493 · Ensite System, Model EE3000 · Endocardial Solutions, Inc. · 2004K030129 · Modification to Ensite 3000 System, Model EE3000 · Endocardial Solutions, Inc. · 2003K012926 · Modification to Ensite 3000 System, Model EE3000 · Endocardial Solutions, Inc. · 2001K001437 · Ensite 3000 System, Model EE3000 · Endocardial Solutions, Inc. · 20000+5+10+15
  1. Root · 4 generations backK001437 Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2000
  2. 3 generations backK012926 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2001
  3. 2 generations backK030129 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2003
  4. 1 generation backK042493 Ensite System, Model EE3000Endocardial Solutions, Inc. · 2004
  5. This deviceK060954 Modification to Ensite System, Model EE3000St. Jude Medical, Inc.-Endocardial Solutions · 2006
  6. Descendant · cites it directly · 47 of its ownK072202 Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External…Biosense Webster, Inc. · 2007
  7. Descendant · 2 generations on · 45 of its ownK090017 Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
  8. Descendant · 3 generations on · 34 of its ownK093455 Carto 3 Version 1.05 EP Navigation System and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
  9. Descendant · 4 generations on · 33 of its ownK103746 Carto 3 EP Navigation System, Version 2.0 (W/Standard Location…Biosense Webster, Inc. · 2011 · Recalled
  10. Descendant · 5 generations on · 32 of its ownK112007 Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc. · 2011 · Recalled

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

2007: 32009: 32010: 12011: 22012: 12013: 12014: 22016: 12017: 22018: 52019: 22020: 22021: 22022: 32023: 52024: 42025: 72026: 5
2007high 7 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 51 · See all
  • K072202Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference Patches…Biosense Webster, Inc. · 2007 · cites it directly47descendants
  • K090017Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc. · 2009 · 2 generations on45descendants
  • K093455Carto 3 Version 1.05 EP Navigation System and AccessoriesBiosense Webster, Inc. · 2009 · 3 generations on34descendants
  • K103746Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3 Epnavigation…Biosense Webster, Inc. · 2011 · 4 generations on33descendants
  • K112007Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc. · 2011 · 5 generations on32descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K001437Ensite 3000 System, Model EE3000Endocardial Solutions, Inc.2000—
−3K012926Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc.2001—
−2K030129Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc.2003—
−1K042493Ensite System, Model EE3000Endocardial Solutions, Inc.2004—
0 (this device)K060954Modification to Ensite System, Model EE3000St. Jude Medical, Inc.-Endocardial Solutions2006—
+1K072202Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference…Biosense Webster, Inc.2007—
+2K090017Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc.20094
+3K093455Carto 3 Version 1.05 EP Navigation System and AccessoriesBiosense Webster, Inc.20091
+4K103746Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3…Biosense Webster, Inc.20111
+5K112007Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc.20112

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200730
200930
201010
201120
201210
201310
201420
201610
201720
201850
201920
202020
202120
202230
202350
202440
202570
202650
FIG. 1 — Lineage of K060954, 2000–2026Source: 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
*K042493Ensite System, Model EE3000
Summary page 1
…CFR 870.1220) b) Programmable diagnostic computer (21 CFR 870.1425) Predicate Device: EnSite System 5 10(k) No. K042493 Device Description: The EnSite System is a computerized storage and display system for use in electrophysiol…
Endocardial Solutions, Inc.2004—

What descends from it? (51)

See all 51

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

NumberDeviceApplicantDecidedDescendants
K072202Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference Patches…Biosense Webster, Inc.200747
K070902Modification to: Ensite System, Model, EE3000St Jude Medical20077

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 2 companies; a new generation was cleared every 1.5 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K072202 (Biosense Webster, Inc., 2007) has gone furthest, with 47 descendants of its own.

How does its category compare?

All DQK devices

DQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 System is indicated for patients for whom electrophysiology studies are indicated.

*When used with the EnSite 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 NavXTM Surface Electrode Kit, the EnSite System is intended to display the position of conventional electrophysiology catheters in the heart.

Indications for use as stated in the FDA summary.

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/K060954 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060954: Modification to Ensite 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/K060954

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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