Devices descending from K043103
42 later devices reach Vigilance II Continuous Cardiac Output/Oximetry/Volumetric Monitor, Model VIG2 through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K163381 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable | Edwards Lifesciences, LLC | 2017 | 41 | 2 |
| +2 | K180881 | HemoSphere Advanced Monitor, HemoSphere Pressure Cable | Edwards Lifesciences, LLC | 2018 | 40 | — |
| +3 | K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot… | Philips Medizin Systeme Böblingen GmbH | 2025 | 1 | — |
| +3 | K251146 | IntelliVue Patient monitors MX400, MX450, MX500, MX550 | Philips Medizin Systeme Boeblingen GmbH | 2025 | 0 | — |
| +3 | K231035 | FusedCO Algorithm | Edwards Lifesciences, LLC | 2023 | 0 | — |
| +3 | K203687 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction… | Edwards Lifesciences, LLC | 2021 | 18 | — |
| +3 | K203131 | EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2021 | 0 | — |
| +3 | K190205 | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | Edwards Lifesciences, LLC | 2019 | 34 | — |
| +3 | K191089 | Edwards Pressure Cable | Edwards Lifesciences, LLC | 2019 | 0 | — |
| +4 | K253654 | IntelliVue Measurement Rack 6000 (867317) | Philips Medizin Systeme Böblingen GmbH | 2026 | 0 | — |
| +4 | K231038 | Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences, LLC | 2023 | 6 | — |
| +4 | K230057 | Acumen Hypotension Prediction Index (HPI) Algorithm | Edwards Lifesciences, LLC | 2023 | 5 | — |
| +4 | K221704 | HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion… | Edwards Lifesciences, LLC | 2022 | 6 | — |
| +4 | K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable… | Edwards Lifesciences, LLC | 2022 | 14 | — |
| +4 | K200717 | CLEWICU System (ClewICUServer and ClewICUnitor) | Clew Medical, Ltd. | 2021 | 12 | — |
| +4 | K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | Edwards Lifesiences, LLC | 2020 | 27 | 1 |
| +5 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere… | Edwards Lifesciences | 2025 | 2 | 1 |
| +5 | K242518 | Hypertension Prediction Index (HePI) Algorithm | Edwards Lifesciences, LLC | 2025 | 0 | — |
| +5 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-… | Edwards Lifesciences | 2024 | 4 | — |
| +5 | K233253 | eCARTv5 Clinical Deterioration Suite (“eCART”) | Agilemd, Inc. | 2024 | 1 | — |
| +5 | K233216 | CLEWICU System | Clew Medical, Ltd. | 2024 | 0 | — |
| +5 | K232294 | HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart… | Edwards Lifesciences, LLC | 2023 | 5 | — |
| +5 | K223865 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid… | Edwards Lifesciences, LLC | 2023 | 7 | — |
| +5 | K223651 | Cerebral Adaptive Index (CAI) Algorithm | Edwards Lifesciences, LLC | 2023 | 6 | — |
| +5 | K221833 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module | Edwards Lifesciences, LLC | 2022 | 7 | — |
| +5 | K223127 | HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable | Edwards Lifeciences, LLC | 2022 | 6 | — |
| +5 | K212219 | AHI System | Fifth Eye, Inc. | 2021 | 1 | — |
| +5 | K203224 | Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform | Edwards Lifesciences, LLC | 2021 | 1 | — |
| +5 | K211465 | HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform | Edwards Lfesciences | 2021 | 15 | — |
| +5 | K203490 | FORE-SIGHT ELITE Absolute Tissue Oximeter | Edwards Lifesciences, LLC | 2021 | 0 | 1 |
| +6 | K260008 | Deterioration Index Version 2 | Epic Systems Corporation | 2026 | 0 | — |
| +6 | K251326 | Respiration Rate algorithm | Edwards Lifesciences, LLC | 2026 | 0 | — |
| +6 | K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026 | 0 | — |
| +6 | K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | 2025 | 0 | — |
| +6 | K253034 | HemoSphere Stream Module | Edwards Lifesciences | 2025 | 0 | — |
| +6 | K240596 | Cerebral Autoregulation Index (CAI) Algorithm | Edwards Lifesciences | 2024 | 0 | — |
| +6 | K233984 | Acumen Assisted Fluid Management (AFM) Software Feature | Edwards Lifesciences, LLC | 2024 | 0 | — |
| +6 | K230612 | Edwards Algorithm for Measurement of Blood Hemoglobin | Edwards Lifesciences, LLC | 2023 | 5 | — |
| +6 | K230842 | SignalHF (IM008) | Implicity, Inc. | 2023 | 0 | — |
| +6 | K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced… | Edwards Lifesciencess, LLC | 2023 | 6 | 2 |
| +6 | K221203 | AHI System | Fifth Eye, Inc. | 2022 | 0 | — |
| +7 | K242909 | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | Edwards Lifesciences, LLC | 2025 | 0 | — |