Devices descending from K020863
101 later devices reach Carto XP and Qwikmap EP Navigation System through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K063277 | Mapmate | Ep Medsystems, Inc. | 2006 | 33 | — |
| +1 | K053194 | Noga XP Cardiac Navigation System with Qwikmap Software | Biosense Webster, Inc. | 2006 | 0 | — |
| +1 | K042999 | Carto XP EP Navigation System, Software Verison 8 | Biosense Webster, Inc. | 2005 | 99 | — |
| +2 | K101331 | Labsystem Pro EP Recording System V3.1 Software | C.R. Bard Inc., Bard Electrophysiology Division | 2010 | 13 | — |
| +2 | K092810 | EP-Workmate System, Version 4.2 | St Jude Medical | 2009 | 32 | — |
| +2 | K070240 | Carto XP EP Navigation System, Version 9 | Biosense Webster, Inc. | 2007 | 58 | — |
| +3 | K132073 | EP-Workmate, EP-Nursemate, EP-Nursemate with Physio Module | St Jude Medical | 2013 | 31 | — |
| +3 | K120550 | Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad) | Biosense Webster, Inc. | 2012 | 31 | 2 |
| +3 | K113811 | V2.6 Software for the Labsystem Pro EP Recording System | C.R. Bard Inc., Bard Electrophysiology Division | 2012 | 12 | — |
| +3 | K093566 | Carto XP EP Navigation System, Version 10 | Biosense Webster, Inc. | 2010 | 14 | — |
| +3 | K091781 | Guided Medical Positioning System (GMPS) | Mediguide, Ltd. | 2009 | 11 | — |
| +3 | K090017 | Carto 3 EP Navigation System, V1.0 and Accessories | Biosense Webster, Inc. | 2009 | 45 | 4 |
| +4 | K201298 | VX1 | Volta Medical | 2020 | 8 | — |
| +4 | K152160 | Navik 3D | Apn Health, LLC | 2016 | 0 | 1 |
| +4 | K151911 | WorkMate Claris System, WorkMate Claris System Display Plus | St Jude Medical | 2015 | 30 | — |
| +4 | K140497 | Ecvue Mapping System | Cardioinsight Technologies, Inc. | 2014 | 8 | — |
| +4 | K133916 | Carto 3 EP Navigation System, Version 4.2 | Biosense Webster, Inc. | 2014 | 27 | 2 |
| +4 | K141185 | V2.7 Software for the Labsystem Pro EP Recording System | Boston Scientific Corp | 2014 | 2 | — |
| +4 | K132782 | CARTO3 EP Navigation System, Version 3.2 | Biosense Webster, Inc. | 2014 | 4 | 1 |
| +4 | K120296 | CPS Direct Mediguide Enabled Outer Catheter | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012 | 1 | — |
| +4 | K120298 | CPS Excel Mediguide Enabled Guidewire | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012 | 8 | — |
| +4 | K093455 | Carto 3 Version 1.05 EP Navigation System and Accessories | Biosense Webster, Inc. | 2009 | 34 | 1 |
| +5 | K250749 | PhysCade System | Physcade, Inc. | 2025 | 0 | — |
| +5 | K233160 | NeuTrace EP Mapping System v.2.1 | Anumana, Inc. | 2023 | 0 | — |
| +5 | K232616 | Volta AF-Xplorer | Volta Medical | 2023 | 2 | — |
| +5 | K230008 | Ablamap® System | Ablacon, Inc. | 2023 | 1 | — |
| +5 | K223516 | VX1+ | Volta Medical | 2023 | 4 | — |
| +5 | K220786 | STAR Apollo Mapping System | Rhythm Al, Ltd. | 2022 | 0 | — |
| +5 | K211546 | Vektor Computational ECG Mapping System (vMap) | Vektor Medical, Inc. | 2021 | 1 | — |
| +5 | K210392 | WorkMate Claris System | Abbott | 2021 | 0 | 3 |
| +5 | K190106 | Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter… | Centerline Biomedical, Inc. | 2019 | 6 | Class I |
| +5 | K180940 | KODEX EPD System | Philips Medical Systems Nederland B.V. | 2018 | 1 | — |
| +5 | K173978 | CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module | Biosense Webster, Inc. | 2018 | 0 | — |
| +5 | K173837 | RHYTHMIA HDx Mapping System (with software Version 2.0) | Boston Scientific Corporation | 2018 | 2 | — |
| +5 | K173977 | CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module | Biosense Webster, Inc. | 2018 | 0 | — |
| +5 | K170600 | CARTO 3 EP Navigation System, Version 6.0 and Accessories | Biosense Webster, Inc. | 2017 | 20 | — |
| +5 | K162793 | RHYTHMIA HDx Mapping System | Boston Scientific Corporation | 2017 | 3 | — |
| +5 | K160218 | AutoMark Module | St Jude Medical | 2016 | 28 | — |
| +5 | K150990 | ECVUE Mapping System | Cardioinsight Technologies, Inc. | 2015 | 7 | — |
| +5 | K142239 | CPS Direct MediGuide Enabled outer catheter | St Jude Medical | 2014 | 0 | — |
| +5 | K142254 | CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel… | St Jude Medical | 2014 | 0 | — |
| +5 | K103746 | Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3 Epnavigation… | Biosense Webster, Inc. | 2011 | 33 | 1 |
| +6 | K252429 | Vektor Computational ECG Mapping System (vMap®) | Vektor Medical, Inc. | 2025 | 0 | — |
| +6 | K251344 | OptiMap™ System | Boston Scientific Corporation | 2025 | 0 | — |
| +6 | K243812 | Volta AF-Xplorer | Volta Medical | 2025 | 1 | — |
| +6 | K243842 | Intra-Operative Positioning System (IOPS®) | Centerline Biomedical, Inc. | 2025 | 2 | Class I |
| +6 | K242133 | Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative… | Centerline Biomedical, Inc. | 2024 | 3 | Class I |
| +6 | K241227 | RHYTHMIA HDx™ Mapping System | Boston Scientific Corporation | 2024 | 0 | — |
| +6 | K241243 | Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)… | Centerline Biomedical, Inc. | 2024 | 3 | Class I |
| +6 | K230309 | Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)… | Centerline Biomedical, Inc. | 2023 | 5 | Class I |
| +6 | K212493 | KODEX – EPD™ System 1.5.0 | Philips Medical Systems Nederland, B.V. (Pmsn) | 2022 | 0 | — |
| +6 | K192438 | Rhythmia HDxTM Mapping System | Boston Scientific Corporation | 2019 | 1 | — |
| +6 | K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT | Biosense Webster, Inc. | 2018 | 19 | — |
| +6 | K172396 | EnSite Velocity Cardiac Mapping System v5.2 | St Jude Medical | 2018 | 27 | — |
| +6 | K162440 | CardioInsight Cardiac Mapping System | Cardioinsight Technologies, Inc. | 2016 | 6 | — |
| +6 | K112007 | Carto 3 EP Navigation System, Version 2.2 | Biosense Webster, Inc. | 2011 | 32 | 2 |
| +7 | K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter… | Centerline Biomedical | 2026 | 0 | — |
| +7 | K253861 | Acorys Mapping System | Corify Care S.L | 2026 | 0 | — |
| +7 | K254089 | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS… | Centerline Biomedical, Inc. | 2026 | 0 | — |
| +7 | K251518 | Volta AF-Xplorer II | Volta Medical | 2025 | 0 | — |
| +7 | K191660 | CARTO 3 EP Navigation System, Version 7.1 and Accessories | Biosense Webster, Inc. | 2019 | 16 | 1 |
| +7 | K183195 | VIVO | Catheter Precision, Inc. | 2019 | 1 | — |
| +7 | K181918 | CardioInsight Cardiac Mapping System | Medtronic, Inc. | 2018 | 2 | — |
| +7 | K182644 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 | Abbott | 2018 | 26 | — |
| +8 | K213264 | CARTO 3 EP Navigation System Version 7.2 | Biosense Webster, Inc. | 2021 | 14 | — |
| +8 | K200484 | CARTO® 3 EP Navigation System with Signal Processing Unit | Biosense Webster, Inc. | 2020 | 15 | — |
| +8 | K200313 | VIVO | Catheter Precision, Inc. | 2020 | 0 | — |
| +8 | K183128 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 | Abbott | 2018 | 25 | — |
| +9 | K233943 | Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart… | Medtronic, Inc. | 2024 | 5 | — |
| +9 | K223733 | CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 | Biosense Webster, Inc. | 2023 | 6 | — |
| +9 | K221112 | CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) | Biosense Webster, Inc. | 2022 | 0 | — |
| +9 | K201181 | EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System | Abbott Medical | 2020 | 18 | — |
| +9 | K201148 | EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation… | Abbott Medical | 2020 | 5 | — |
| +10 | K241828 | Affera Integrated Mapping System; Impedance Localization Patch Kit | Medtronic, Inc. | 2024 | 4 | — |
| +10 | K231207 | CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | Biosense Webster, Inc. | 2023 | 5 | — |
| +10 | K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL… | Abbott Medical | 2020 | 17 | — |
| +11 | K252164 | NorthStar™ Mapping System | Imricor Medical Systems | 2026 | 1 | — |
| +11 | K252302 | CARTO™ 3 EP Navigation System V8.1 | Biosense Webster, Inc. | 2025 | 2 | — |
| +11 | K250747 | Globe® Pulsed Field System | Kardium, Inc. | 2025 | 0 | — |
| +11 | K251211 | ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid… | Abbott Medical | 2025 | 2 | — |
| +11 | K243892 | Affera Integrated Mapping System | Medtronic, Inc. | 2025 | 1 | — |
| +11 | K243435 | Magnetic Localization Patch Kit (AFR-00021) | Medtronic, Inc. | 2024 | 0 | — |
| +11 | K212061 | EnSite X EP System | Abbott | 2021 | 13 | — |
| +12 | K262005 | Affera Integrated Mapping System | Medtronic, Inc. | 2026 | 0 | — |
| +12 | K261119 | NorthStar Mapping System (MAP01 or MAP01-01) | Imricor Medical Systems, Inc. | 2026 | 0 | — |
| +12 | K252972 | CARTO™ 3 EP Navigation System V8.4 | Biosense Webster, Inc. | 2026 | 0 | — |
| +12 | K254085 | CARTO™ 3 EP Navigation System V9.0 with PIU Plus | Biosense Webster, Inc. | 2026 | 0 | — |
| +12 | K250305 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health | 2026 | 0 | — |
| +12 | K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer | Surgical Instrument Service and Savings, Inc. | 2025 | 0 | — |
| +12 | K213364 | EnSite X EP System | Abbott Medical | 2021 | 12 | — |
| +13 | K221213 | EnSite X EP System | Abbott | 2022 | 11 | — |
| +14 | K223094 | EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade… | Abbott Medical | 2022 | 10 | — |
| +15 | K231415 | EnSite™ X EP System | Abbott Medical | 2023 | 9 | — |
| +16 | K242016 | EnSite™ X EP System | Abbott Medical | 2024 | 8 | — |
| +17 | K252013 | EnSite™ X EP System | Abbott Medical | 2025 | 3 | — |
| +17 | K251463 | EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP… | Abbott Medical | 2025 | 0 | — |
| +17 | K251234 | EnSite™ X EP System | Abbott Medical | 2025 | 4 | — |
| +18 | K260885 | VERAFEYE Imaging and Guidance System (VF-VIS-002) | Luma Vision Limited | 2026 | 0 | — |
| +18 | K260212 | EnSite™ X EP System | Abbott Medical | 2026 | 2 | — |
| +19 | K261729 | EnSite™ X EP System | Abbott Medical | 2026 | 0 | — |