510(k) Report

Devices descending from K101419

66 later devices reach Ensite Velocity System, Model EE3000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical201628—
+1K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+2K172396EnSite Velocity Cardiac Mapping System v5.2St Jude Medical201827—
+2K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+2K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+3K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+3K220111RespiraSensePmd Solutions20221—
+3K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+3K182644EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2Abbott201826—
+3K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+3K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+4K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+4K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+4K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+4K183128EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2Abbott201825—
+4K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+4K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+5K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+5K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+5K201181EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping SystemAbbott Medical202018—
+5K201148EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation…Abbott Medical20205—
+5K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+5K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+6K241828Affera Integrated Mapping System; Impedance Localization Patch KitMedtronic, Inc.20244—
+6K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+6K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+6K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL…Abbott Medical202017—
+6K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+6K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+7K250747Globe® Pulsed Field SystemKardium, Inc.20250—
+7K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid…Abbott Medical20252—
+7K243892Affera Integrated Mapping SystemMedtronic, Inc.20251—
+7K243435Magnetic Localization Patch Kit (AFR-00021)Medtronic, Inc.20240—
+7K241397HinscopeHinlab Sas20240—
+7K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+7K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+7K222550Current Health SystemCurrent Health, Ltd.20221—
+7K212061EnSite X EP SystemAbbott202113—
+7K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+8K262005Affera Integrated Mapping SystemMedtronic, Inc.20260—
+8K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health20260—
+8K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.20250—
+8K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+8K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+8K232915EpiMonitorEmpatica S.r.l.20241—
+8K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+8K231506Current Health SystemCurrent Health, Ltd.20230—
+8K213364EnSite X EP SystemAbbott Medical202112—
+9K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+9K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+9K252981EmbraceMiniEmpatica S.r.l.20251—
+9K250515EpiMonitorEmpatica S.r.l.20250—
+9K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+9K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+9K221213EnSite X EP SystemAbbott202211—
+10K223094EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade…Abbott Medical202210—
+11K231415EnSite™ X EP SystemAbbott Medical20239—
+12K242016EnSite™ X EP SystemAbbott Medical20248—
+13K252429Vektor Computational ECG Mapping System (vMap®)Vektor Medical, Inc.20250—
+13K252013EnSite™ X EP SystemAbbott Medical20253—
+13K251463EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP…Abbott Medical20250—
+13K251234EnSite™ X EP SystemAbbott Medical20254—
+14K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+14K260212EnSite™ X EP SystemAbbott Medical20262—
+15K261729EnSite™ X EP SystemAbbott Medical20260—
+15K262006EnSite™ X EP SystemAbbott Medical20260—