510(k) Report

510(k) · Cleared

Cleared

CARTO 3 EP Navigation System Version 7.2

K213264510(k) SpecialCleared Oct 29, 202129-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

Biosense Webster, Inc. · DQK Computer, Diagnostic, Programmable

Cleared on Oct 29, 2021 as substantially equivalent to K191660 (Biosense Webster, Inc., 2019) and 1 other predicate after a 29-day review. Its family tree reaches back 16 generations to 2000. 14 later devices descend from it.

Decided
Oct 29, 2021
Review
29 days
Class
Class II
Product code
DQK
Recalls
None
Predicates
2

Its longest line of descent runs back 16 generations to K001437 (2000). 27 ancestors in all, the oldest K982415 (1998). 14 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2006: 3 other ancestors2005: 1 other ancestor2010: 2 other ancestors2003: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1998: 1 other ancestor2024: 3 descendants cleared2023: 2 descendants cleared2022: 1 descendant cleared2025: 3 descendants 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. · 2004K060954 · Modification to Ensite System, Model EE3000 · St. Jude Medical, Inc.-Endocardial Solutions · 2006K072202 · Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference Patches (Model:D-1283-01) · Biosense Webster, Inc. · 2007×2: 2 generations cleared close together, K090017 (2009), K093455 (2009) K103746 · Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3 Epnavigation System,Version 2.0 W/RMT Pad) · Biosense Webster, Inc. · 2011 · recalledK112007 · Carto 3 EP Navigation System, Version 2.2 · Biosense Webster, Inc. · 2011 · recalledK120550 · Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad) · Biosense Webster, Inc. · 2012 · recalledK133916 · Carto 3 EP Navigation System, Version 4.2 · Biosense Webster, Inc. · 2014 · recalledK170600 · CARTO 3 EP Navigation System, Version 6.0 and Accessories · Biosense Webster, Inc. · 2017K180238 · CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT · Biosense Webster, Inc. · 2018K191660 · CARTO 3 EP Navigation System, Version 7.1 and Accessories · Biosense Webster, Inc. · 2019 · recalledK200484 · CARTO® 3 EP Navigation System with Signal Processing Unit · Biosense Webster, Inc. · 20201995200020052010201520202025
Other ancestors, by generationDescendants, by generation 6 generations back: 2 other ancestors7 generations back: 1 other ancestor8 generations back: 2 other ancestors9 generations back: 2 other ancestors10 generations back: 2 other ancestors11 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 5 descendants4 generations forward: 4 descendants K200484 · CARTO® 3 EP Navigation System with Signal Processing Unit · Biosense Webster, Inc. · 2020K191660 · CARTO 3 EP Navigation System, Version 7.1 and Accessories · Biosense Webster, Inc. · 2019 · recalledK180238 · CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT · Biosense Webster, Inc. · 2018K170600 · CARTO 3 EP Navigation System, Version 6.0 and Accessories · Biosense Webster, Inc. · 2017K133916 · Carto 3 EP Navigation System, Version 4.2 · Biosense Webster, Inc. · 2014 · recalledK120550 · Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad) · Biosense Webster, Inc. · 2012 · recalledK112007 · Carto 3 EP Navigation System, Version 2.2 · Biosense Webster, Inc. · 2011 · recalledK103746 · Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3 Epnavigation System,Version 2.0 W/RMT Pad) · Biosense Webster, Inc. · 2011 · recalledK093455 · Carto 3 Version 1.05 EP Navigation System and Accessories · Biosense Webster, Inc. · 2009 · recalledK090017 · Carto 3 EP Navigation System, V1.0 and Accessories · Biosense Webster, Inc. · 2009 · recalledK072202 · Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference Patches (Model:D-1283-01) · Biosense Webster, Inc. · 2007K060954 · Modification to Ensite System, Model EE3000 · St. Jude Medical, Inc.-Endocardial Solutions · 2006K042493 · 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. · 2000−15−10−50
  1. Root · 16 generations backK001437 Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2000
  2. 12 generations between
  3. 3 generations backK180238 CARTO 3 EP Navigation System, Version 6.0 and Accessories with…Biosense Webster, Inc. · 2018
  4. 2 generations backK191660 CARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc. · 2019 · Recalled
  5. 1 generation backK200484 CARTO® 3 EP Navigation System with Signal Processing UnitBiosense Webster, Inc. · 2020
  6. This deviceK213264 CARTO 3 EP Navigation System Version 7.2Biosense Webster, Inc. · 2021
  7. Descendant · cites it directly · 6 of its ownK223733 CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4Biosense Webster, Inc. · 2023
  8. Descendant · cites it directly · 5 of its ownK233943 Affera Mapping System (AFR-00003); Location Reference Patch Kit…Medtronic, Inc. · 2024
  9. Descendant · 2 generations on · 5 of its ownK231207 CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)Biosense Webster, Inc. · 2023
  10. Descendant · 2 generations on · 4 of its ownK241828 Affera Integrated Mapping System; Impedance Localization Patch KitMedtronic, Inc. · 2024
  11. Descendant · 3 generations on · 2 of its ownK252302 CARTO™ 3 EP Navigation System V8.1Biosense Webster, Inc. · 2025
Show all 16 generations
  1. Root · 16 generations backK001437 Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2000
  2. 15 generations backK012926 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2001
  3. 14 generations backK030129 Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc. · 2003
  4. 13 generations backK042493 Ensite System, Model EE3000Endocardial Solutions, Inc. · 2004
  5. 12 generations backK060954 Modification to Ensite System, Model EE3000St. Jude Medical, Inc.-Endocardial Solutions · 2006
  6. 11 generations backK072202 Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External…Biosense Webster, Inc. · 2007
  7. 10 generations backK090017 Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
  8. 9 generations backK093455 Carto 3 Version 1.05 EP Navigation System and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
  9. 8 generations backK103746 Carto 3 EP Navigation System, Version 2.0 (W/Standard Location…Biosense Webster, Inc. · 2011 · Recalled
  10. 7 generations backK112007 Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc. · 2011 · Recalled
  11. 6 generations backK120550 Carto (R) EP Navigation System, Version 3.0 (with Standard Location…Biosense Webster, Inc. · 2012 · Recalled
  12. 5 generations backK133916 Carto 3 EP Navigation System, Version 4.2Biosense Webster, Inc. · 2014 · Recalled
  13. 4 generations backK170600 CARTO 3 EP Navigation System, Version 6.0 and AccessoriesBiosense Webster, Inc. · 2017
  14. 3 generations backK180238 CARTO 3 EP Navigation System, Version 6.0 and Accessories with…Biosense Webster, Inc. · 2018
  15. 2 generations backK191660 CARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc. · 2019 · Recalled
  16. 1 generation backK200484 CARTO® 3 EP Navigation System with Signal Processing UnitBiosense Webster, Inc. · 2020
  17. This deviceK213264 CARTO 3 EP Navigation System Version 7.2Biosense Webster, Inc. · 2021

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2022: 12023: 22024: 32025: 32026: 5
2022high 5 (2026) · low 1 (2022)2026

Most influential descendants

Showing 5 of 14 · See all
  • K223733CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4Biosense Webster, Inc. · 2023 · cites it directly6descendants
  • K233943Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart…Medtronic, Inc. · 2024 · cites it directly5descendants
  • K231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)Biosense Webster, Inc. · 2023 · 2 generations on5descendants
  • K241828Affera Integrated Mapping System; Impedance Localization Patch KitMedtronic, Inc. · 2024 · 2 generations on4descendants
  • K252302CARTO™ 3 EP Navigation System V8.1Biosense Webster, Inc. · 2025 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K001437Ensite 3000 System, Model EE3000Endocardial Solutions, Inc.2000—
−15K012926Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc.2001—
−14K030129Modification to Ensite 3000 System, Model EE3000Endocardial Solutions, Inc.2003—
−13K042493Ensite System, Model EE3000Endocardial Solutions, Inc.2004—
−12K060954Modification to Ensite System, Model EE3000St. Jude Medical, Inc.-Endocardial Solutions2006—
−11K072202Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference…Biosense Webster, Inc.2007—
−10K090017Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc.20094
−9K093455Carto 3 Version 1.05 EP Navigation System and AccessoriesBiosense Webster, Inc.20091
−8K103746Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3…Biosense Webster, Inc.20111
−7K112007Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc.20112
−6K120550Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad)Biosense Webster, Inc.20122
−5K133916Carto 3 EP Navigation System, Version 4.2Biosense Webster, Inc.20142
−4K170600CARTO 3 EP Navigation System, Version 6.0 and AccessoriesBiosense Webster, Inc.2017—
−3K180238CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINTBiosense Webster, Inc.2018—
−2K191660CARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc.20191
−1K200484CARTO® 3 EP Navigation System with Signal Processing UnitBiosense Webster, Inc.2020—
0 (this device)K213264CARTO 3 EP Navigation System Version 7.2Biosense Webster, Inc.2021—
+1K223733CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4Biosense Webster, Inc.2023—
+1K233943Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007)…Medtronic, Inc.2024—
+2K231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)Biosense Webster, Inc.2023—
+2K241828Affera Integrated Mapping System; Impedance Localization Patch KitMedtronic, Inc.2024—
+3K252302CARTO™ 3 EP Navigation System V8.1Biosense Webster, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200010
200110
200310
200510
200630
200710
201020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
202320
202430
202530
202650
FIG. 1 — Lineage of K213264, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K191660CARTO 3 EP Navigation System, Version 7.1 and Accessories
Summary page 4
…assification: Class II, 21 CFR 870.1425 Product Code DQK Predicate CARTO® 3 EP Navigation System Version 7.1 510(k)#: K191660 (primary Device: predicate device) and CARTO® 3 EP Navigation System Version 7.61 with SPU…
Biosense Webster, Inc.20191
*K200484CARTO® 3 EP Navigation System with Signal Processing Unit
Summary page 4
…60 (primary Device: predicate device) and CARTO® 3 EP Navigation System Version 7.61 with SPU (Signal Processing Unit) 510(k)#: K200484 The intended use of the CARTO® 3 System is catheter-based cardiac Indications for…
Biosense Webster, Inc.2020—

Also cleared against K191660: 1 other device →

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K223733CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4Biosense Webster, Inc.20236
K233943Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart…Medtronic, Inc.20245
K221112CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)Biosense Webster, Inc.20220

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 21 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
  • 7 of the 27 ancestors have a recall of any class.
  • Of its descendants, K223733 (Biosense Webster, Inc., 2023) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K191660.

How does its category compare?

All DQK devices

DQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 intended use of the CARTO® 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO® 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.

Indications for use as stated in the FDA summary.

Also cleared against K191660

1 other device cites the same predicate.

  • K200484CARTO® 3 EP Navigation System with Signal Processing UnitBiosense Webster, Inc. · 2020

More from Biosense Webster, Inc.

638 FDA decisions under this applicant name. See the company

  • P030031/S146EZ Steer Thermocool Nav BI-Directional Electrophysiology Catheter; Thermocool Smarttouch BI-Directional…Biosense Webster, Inc. · 2026
  • P240006/S020Varipulse BI-Directional CatheterBiosense Webster, Inc. · 2026
  • P040036/S101Thermocool Smarttouch BI-Directional Navigation Catheter; Thermocool Smarttouch Uni-Directional Navigation…Biosense Webster, Inc. · 2026
  • P210027/S019Qdot Micro BI-Directional Navigation Catheter; Qdot Micro Uni-Directional Navigation CatheterBiosense Webster, Inc. · 2026
  • P210027/S018QDOT MICRO™ SystemBiosense Webster, Inc. · 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/K213264 · printed Nov 6, 2026

Cite this page

510(k) Report. “K213264: CARTO 3 EP Navigation System Version 7.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213264

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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