Devices descending from K093942
119 later devices reach Ensite Velocity System V1.3 through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K101328 | Ensite Velocity System | St Jude Medical | 2010 | 34 | — |
| +1 | K101667 | Ensite Velocity System Referred to Ensite Velocity System with Positional Reference Tool… | St Jude Medical | 2010 | 50 | — |
| +1 | K101419 | Ensite Velocity System, Model EE3000 | St Jude Medical | 2010 | 66 | — |
| +2 | K160187 | Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 | St Jude Medical | 2016 | 28 | — |
| +2 | K112688 | Ensite Velocity System V.3.0 | St Jude Medical | 2011 | 48 | — |
| +2 | K111905 | Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | 36 | — |
| +2 | K110549 | Ensite Velocity System | St Jude Medical | 2011 | 29 | — |
| +2 | K103746 | Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3 Epnavigation… | Biosense Webster, Inc. | 2011 | 33 | 1 |
| +3 | K172396 | EnSite Velocity Cardiac Mapping System v5.2 | St Jude Medical | 2018 | 27 | — |
| +3 | K131913 | Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T… | Philips Medizin Systeme Boeblingen GmbH | 2013 | 0 | 1 |
| +3 | K130727 | Ensite Velocity System | St Jude Medical | 2013 | 29 | — |
| +3 | K130594 | Ensite Velocity System | St Jude Medical | 2013 | 46 | — |
| +3 | K122223 | New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment… | Philips Medizin Systeme Boeblingen GmbH | 2013 | 35 | — |
| +3 | K112007 | Carto 3 EP Navigation System, Version 2.2 | Biosense Webster, Inc. | 2011 | 32 | 2 |
| +4 | K223681 | Respiree Cardio-Respiratory Monitor | Respiree Pte, Ltd. | 2023 | 1 | — |
| +4 | K220111 | RespiraSense | Pmd Solutions | 2022 | 1 | — |
| +4 | K201941 | Monitor B125, Monitor B105 | Ge Medical Systems Information Technologies, Inc. | 2020 | 3 | — |
| +4 | K182644 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 | Abbott | 2018 | 26 | — |
| +4 | K170948 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2017 | 11 | — |
| +4 | K151736 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boblingen GmbH | 2015 | 24 | — |
| +4 | K141050 | Ensite Velocity System | St Jude Medical | 2014 | 33 | — |
| +4 | K132320 | Intellivue CL Respiration Pod | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2014 | 20 | — |
| +4 | K120550 | Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad) | Biosense Webster, Inc. | 2012 | 31 | 2 |
| +5 | K250934 | Respiree Cardio- Respiratory Monitor System | Respiree Pte, Ltd. | 2025 | 0 | — |
| +5 | K233953 | Makani Science™ Respiration Monitoring System | Makani Science, Inc. | 2025 | 0 | — |
| +5 | K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2022 | 2 | 6 |
| +5 | K190131 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2019 | 9 | — |
| +5 | K181577 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2019 | 0 | — |
| +5 | K183128 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 | Abbott | 2018 | 25 | — |
| +5 | K182543 | Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device… | Snap40, Ltd. | 2018 | 19 | — |
| +5 | K161767 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | 2017 | 23 | — |
| +5 | K160218 | AutoMark Module | St Jude Medical | 2016 | 28 | — |
| +5 | K160210 | EnSite Precision Cardiac Mapping System v2.0 | St Jude Medical | 2016 | 29 | — |
| +5 | K160186 | EnSite Velocity Surface Electrode Kit | St Jude Medical | 2016 | 1 | — |
| +5 | K152160 | Navik 3D | Apn Health, LLC | 2016 | 0 | 1 |
| +5 | K133916 | Carto 3 EP Navigation System, Version 4.2 | Biosense Webster, Inc. | 2014 | 27 | 2 |
| +5 | K132782 | CARTO3 EP Navigation System, Version 3.2 | Biosense Webster, Inc. | 2014 | 4 | 1 |
| +6 | K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2025 | 0 | — |
| +6 | K233810 | Portrait VSM | Ge Medical Systems Information Technologies, Inc. | 2024 | 0 | 1 |
| +6 | K233160 | NeuTrace EP Mapping System v.2.1 | Anumana, Inc. | 2023 | 0 | — |
| +6 | K201094 | iMap 3D Mapping & Navigation System (iMap System) | Cardionxt, Inc. | 2021 | 0 | — |
| +6 | K201181 | EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System | Abbott Medical | 2020 | 18 | — |
| +6 | K201148 | EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation… | Abbott Medical | 2020 | 5 | — |
| +6 | K191392 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2019 | 8 | — |
| +6 | K190073 | Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case… | Current Health, Ltd. | 2019 | 18 | — |
| +6 | K180940 | KODEX EPD System | Philips Medical Systems Nederland B.V. | 2018 | 1 | — |
| +6 | K173978 | CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module | Biosense Webster, Inc. | 2018 | 0 | — |
| +6 | K173837 | RHYTHMIA HDx Mapping System (with software Version 2.0) | Boston Scientific Corporation | 2018 | 2 | — |
| +6 | K180534 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | 2018 | 2 | — |
| +6 | K173977 | CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module | Biosense Webster, Inc. | 2018 | 0 | — |
| +6 | K170600 | CARTO 3 EP Navigation System, Version 6.0 and Accessories | Biosense Webster, Inc. | 2017 | 20 | — |
| +6 | K162793 | RHYTHMIA HDx Mapping System | Boston Scientific Corporation | 2017 | 3 | — |
| +7 | K241828 | Affera Integrated Mapping System; Impedance Localization Patch Kit | Medtronic, Inc. | 2024 | 4 | — |
| +7 | K241227 | RHYTHMIA HDx™ Mapping System | Boston Scientific Corporation | 2024 | 0 | — |
| +7 | K212493 | KODEX – EPD™ System 1.5.0 | Philips Medical Systems Nederland, B.V. (Pmsn) | 2022 | 0 | — |
| +7 | K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X) | Philips Medizin Systeme Boeblingen GmbH | 2021 | 0 | — |
| +7 | K202189 | Graffiti | Ge Medical Systems Information Technologies, Inc. | 2020 | 0 | — |
| +7 | K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL… | Abbott Medical | 2020 | 17 | — |
| +7 | K192952 | Spire Health Remote Patient Monitoring System | Spire, Inc. D/B/A Spire Health | 2020 | 0 | — |
| +7 | K193013 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2020 | 7 | — |
| +7 | K192438 | Rhythmia HDxTM Mapping System | Boston Scientific Corporation | 2019 | 1 | — |
| +7 | K191272 | Wearable Device, Wearable Package | Current Health, Ltd. | 2019 | 16 | — |
| +7 | K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT | Biosense Webster, Inc. | 2018 | 19 | — |
| +8 | K250747 | Globe® Pulsed Field System | Kardium, Inc. | 2025 | 0 | — |
| +8 | K251211 | ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid… | Abbott Medical | 2025 | 2 | — |
| +8 | K243892 | Affera Integrated Mapping System | Medtronic, Inc. | 2025 | 1 | — |
| +8 | K243435 | Magnetic Localization Patch Kit (AFR-00021) | Medtronic, Inc. | 2024 | 0 | — |
| +8 | K241397 | Hinscope | Hinlab Sas | 2024 | 0 | — |
| +8 | K213863 | Everion+ System | Biofourmis Singapore Pte., Ltd. | 2023 | 1 | — |
| +8 | K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | 2022 | 7 | — |
| +8 | K222550 | Current Health System | Current Health, Ltd. | 2022 | 1 | — |
| +8 | K212061 | EnSite X EP System | Abbott | 2021 | 13 | — |
| +8 | K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | 2021 | 8 | — |
| +8 | K210680 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2021 | 0 | — |
| +8 | K201015 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2020 | 5 | — |
| +8 | K191660 | CARTO 3 EP Navigation System, Version 7.1 and Accessories | Biosense Webster, Inc. | 2019 | 16 | 1 |
| +9 | K262005 | Affera Integrated Mapping System | Medtronic, Inc. | 2026 | 0 | — |
| +9 | K250305 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health | 2026 | 0 | — |
| +9 | K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer | Surgical Instrument Service and Savings, Inc. | 2025 | 0 | — |
| +9 | K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. | 2024 | 0 | — |
| +9 | K232548 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2024 | 1 | — |
| +9 | K232915 | EpiMonitor | Empatica S.r.l. | 2024 | 1 | — |
| +9 | K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2023 | 4 | — |
| +9 | K231506 | Current Health System | Current Health, Ltd. | 2023 | 0 | — |
| +9 | K213364 | EnSite X EP System | Abbott Medical | 2021 | 12 | — |
| +9 | K213264 | CARTO 3 EP Navigation System Version 7.2 | Biosense Webster, Inc. | 2021 | 14 | — |
| +9 | K212345 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2021 | 4 | — |
| +9 | K200484 | CARTO® 3 EP Navigation System with Signal Processing Unit | Biosense Webster, Inc. | 2020 | 15 | — |
| +10 | K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus… | Empatica S.r.l. | 2026 | 0 | — |
| +10 | K261367 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2026 | 0 | — |
| +10 | K252981 | EmbraceMini | Empatica S.r.l. | 2025 | 1 | — |
| +10 | K250515 | EpiMonitor | Empatica S.r.l. | 2025 | 0 | — |
| +10 | K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2025 | 0 | — |
| +10 | K240236 | Happy Ring Health Monitoring System | Happy Health, Inc. | 2024 | 0 | — |
| +10 | K233943 | Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart… | Medtronic, Inc. | 2024 | 5 | — |
| +10 | K223733 | CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 | Biosense Webster, Inc. | 2023 | 6 | — |
| +10 | K221213 | EnSite X EP System | Abbott | 2022 | 11 | — |
| +10 | K221112 | CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) | Biosense Webster, Inc. | 2022 | 0 | — |
| +10 | K220784 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | 2022 | 3 | — |
| +11 | K231207 | CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | Biosense Webster, Inc. | 2023 | 5 | — |