510(k) Report

Devices descending from K963033

573 later devices reach BF 240/P240/IT240 Bronchovideoscope & Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+10K232003Endoscopic Video Image Processor, Single-Use Video HysteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.20243—
+10K233216CLEWICU SystemClew Medical, Ltd.20240—
+10K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+10K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+10K222737Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)Shanghai AnQing Medical Instrument Co., Ltd.20220—
+10K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+10K214072Masimo O3 Regional Oximeter SystemMasimo Corporation20221—
+10K212219AHI SystemFifth Eye, Inc.20211—
+10K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+10K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+10K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+10K191394ILLUMISITE PlatformCovidien, LLC201901
+10K190639Endosee SystemCooperSurgical, Inc.201931
+10K160510MAKO 7Nvision Medical Corporation20161—
+10K122106Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip Tracked Sheath…Veran Medical Technologies, Inc.2012113
+10K110256The IC-Pro SystemPaieon, Inc.201115—
+10K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV201013—
+10K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd.200911—
+10K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+11K260008Deterioration Index Version 2Epic Systems Corporation20260—
+11K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+11K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+11K252806Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US…Shanghai AnQing Medical Instrument Co., Ltd.20250—
+11K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+11K243324Masimo O3 Regional OximeterMasimo Corporation20250—
+11K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+11K240978SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G…MacroLux Medical Technology Co., Ltd.20241—
+11K241987Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)Guangzhou Red Pine Medical Instrument Co., Ltd.20240—
+11K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+11K230842SignalHF (IM008)Implicity, Inc.20230—
+11K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+11K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+11K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+11K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+11K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+11K221203AHI SystemFifth Eye, Inc.20220—
+11K200038Endosee SystemCooperSurgical, Inc.20201—
+11K182975MAKO 7Boston Scientific Corporation20190—
+11K133993Caas WorkstationPie Medical Imaging201410—
+11K120282CardnavPaieon, Inc.20120—
+11K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi20121—
+11K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi20128—
+11K113594C-THV SystemPaieon, Inc.20120—
+11K113076Caas a-ValvePie Medical Imaging BV20121—
+12K254294Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A…Zhejiang Geyi Medical Instrument Co., Ltd.20260—
+12K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+12K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd.20260—
+12K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+12K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+12K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+12K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+12K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+12K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+12K151780CAAS WorkstationPie Medical Imaging BV20169—
+12K143044CAAS A-ValvePie Medical Imaging BV20150—
+12K142239CPS Direct MediGuide Enabled outer catheterSt Jude Medical20140—
+12K142254CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel…St Jude Medical20140—
+13K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+13K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+13K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+13K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+13K180019CAAS WorkstationPie Medical Imaging BV20188—
+14K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+14K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+14K251355X1-FFRSpectrawave, Inc.20250—
+14K232147CAAS WorkstationPie Medical Imaging BV20241—
+14K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+15K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+15K243769QFR (3.0)Qfr Solutions BV20250—
+15K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+16K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+16K221711AccuICASArteryFlow Technology Co., Ltd.20230—