Devices descending from K931154
652 later devices reach Evis 200 System through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +11 | K254251 | InnovexView (GC146-17, GC150-20, GC155-23) | Shanghai AnQing Medical Instrument Co., Ltd. | 2026 | 0 | — |
| +11 | K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | 2025 | 0 | — |
| +11 | K251994 | Arthrex Synergy Vision Imaging System | Arthrex, Inc. | 2025 | 0 | — |
| +11 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere… | Edwards Lifesciences | 2025 | 2 | 1 |
| +11 | K243324 | Masimo O3 Regional Oximeter | Masimo Corporation | 2025 | 0 | — |
| +11 | K242518 | Hypertension Prediction Index (HePI) Algorithm | Edwards Lifesciences, LLC | 2025 | 0 | — |
| +11 | K232294 | HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart… | Edwards Lifesciences, LLC | 2023 | 5 | — |
| +11 | K230842 | SignalHF (IM008) | Implicity, Inc. | 2023 | 0 | — |
| +11 | K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced… | Edwards Lifesciencess, LLC | 2023 | 6 | 2 |
| +11 | K223865 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid… | Edwards Lifesciences, LLC | 2023 | 7 | — |
| +11 | K230057 | Acumen Hypotension Prediction Index (HPI) Algorithm | Edwards Lifesciences, LLC | 2023 | 5 | — |
| +11 | K223651 | Cerebral Adaptive Index (CAI) Algorithm | Edwards Lifesciences, LLC | 2023 | 6 | — |
| +11 | K221704 | HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion… | Edwards Lifesciences, LLC | 2022 | 6 | — |
| +11 | K221203 | AHI System | Fifth Eye, Inc. | 2022 | 0 | — |
| +11 | K191394 | ILLUMISITE Platform | Covidien, LLC | 2019 | 0 | 1 |
| +11 | K122106 | Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip Tracked Sheath… | Veran Medical Technologies, Inc. | 2012 | 1 | 13 |
| +11 | K110256 | The IC-Pro System | Paieon, Inc. | 2011 | 15 | — |
| +11 | K100292 | Caas Qva 3D, Caas Qca 3D | Pie Medical Imaging BV | 2010 | 13 | — |
| +11 | K091781 | Guided Medical Positioning System (GMPS) | Mediguide, Ltd. | 2009 | 11 | — |
| +11 | K092004 | GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQ | GE Healthcare | 2009 | 0 | 2 |
| +12 | K251326 | Respiration Rate algorithm | Edwards Lifesciences, LLC | 2026 | 0 | — |
| +12 | K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026 | 0 | — |
| +12 | K253034 | HemoSphere Stream Module | Edwards Lifesciences | 2025 | 0 | — |
| +12 | K242909 | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | Edwards Lifesciences, LLC | 2025 | 0 | — |
| +12 | K240596 | Cerebral Autoregulation Index (CAI) Algorithm | Edwards Lifesciences | 2024 | 0 | — |
| +12 | K233984 | Acumen Assisted Fluid Management (AFM) Software Feature | Edwards Lifesciences, LLC | 2024 | 0 | — |
| +12 | K133993 | Caas Workstation | Pie Medical Imaging | 2014 | 10 | — |
| +12 | K120282 | Cardnav | Paieon, Inc. | 2012 | 0 | — |
| +12 | K120296 | CPS Direct Mediguide Enabled Outer Catheter | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012 | 1 | — |
| +12 | K120298 | CPS Excel Mediguide Enabled Guidewire | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012 | 8 | — |
| +12 | K113594 | C-THV System | Paieon, Inc. | 2012 | 0 | — |
| +12 | K113076 | Caas a-Valve | Pie Medical Imaging BV | 2012 | 1 | — |
| +13 | K190106 | Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter… | Centerline Biomedical, Inc. | 2019 | 6 | Class I |
| +13 | K151780 | CAAS Workstation | Pie Medical Imaging BV | 2016 | 9 | — |
| +13 | K143044 | CAAS A-Valve | Pie Medical Imaging BV | 2015 | 0 | — |
| +13 | K142239 | CPS Direct MediGuide Enabled outer catheter | St Jude Medical | 2014 | 0 | — |
| +13 | K142254 | CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel… | St Jude Medical | 2014 | 0 | — |
| +14 | K243842 | Intra-Operative Positioning System (IOPS®) | Centerline Biomedical, Inc. | 2025 | 2 | Class I |
| +14 | K242133 | Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative… | Centerline Biomedical, Inc. | 2024 | 3 | Class I |
| +14 | K241243 | Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)… | Centerline Biomedical, Inc. | 2024 | 3 | Class I |
| +14 | K230309 | Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)… | Centerline Biomedical, Inc. | 2023 | 5 | Class I |
| +14 | K180019 | CAAS Workstation | Pie Medical Imaging BV | 2018 | 8 | — |
| +15 | K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter… | Centerline Biomedical | 2026 | 0 | — |
| +15 | K254089 | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS… | Centerline Biomedical, Inc. | 2026 | 0 | — |
| +15 | K251355 | X1-FFR | Spectrawave, Inc. | 2025 | 0 | — |
| +15 | K232147 | CAAS Workstation | Pie Medical Imaging BV | 2024 | 1 | — |
| +15 | K182611 | Qangio XA 3D | Medis Medical Imaging Systems BV | 2019 | 4 | — |
| +16 | K243632 | uWS-Angio Basic | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | 0 | — |
| +16 | K243769 | QFR (3.0) | Qfr Solutions BV | 2025 | 0 | — |
| +16 | K210093 | AccuFFRangio | ArteryFlow Technology Co., Ltd. | 2021 | 2 | — |
| +17 | K230303 | AccuFFRangio Plus | ArteryFlow Technology Co., Ltd. | 2023 | 0 | — |
| +17 | K221711 | AccuICAS | ArteryFlow Technology Co., Ltd. | 2023 | 0 | — |