Devices descending from K080238
219 later devices reach Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87… through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +5 | K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced… | Edwards Lifesciencess, LLC | 2023 | 6 | 2 |
| +5 | K223574 | IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)… | Philips Medizin Systeme Boeblingen GmbH | 2023 | 2 | — |
| +5 | K221348 | IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470) | Philips Medizin Systeme Böblingen GmbH | 2023 | 3 | — |
| +5 | K222010 | Biobeat Platform-2 and BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | 1 | — |
| +5 | K220530 | Tetragraph Neuromuscular Transmission Monitor | Senzime AB | 2022 | 1 | — |
| +5 | K203113 | Masimo SedLine Sedation Monitor and Accessories | Masimo Corporation | 2022 | 1 | — |
| +5 | K202375 | ZOLL Propaq M | ZOLL Medical Corporation | 2021 | 1 | — |
| +5 | K203131 | EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2021 | 0 | — |
| +5 | K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | Edwards Lifesiences, LLC | 2020 | 27 | 1 |
| +5 | K192952 | Spire Health Remote Patient Monitoring System | Spire, Inc. D/B/A Spire Health | 2020 | 0 | — |
| +5 | K193179 | EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2019 | 0 | — |
| +5 | K191106 | C50 and C80 Multi-parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | 2019 | 1 | — |
| +5 | K183521 | CNAP Monitor | Cnsystems Medizintechnik GmbH | 2019 | 1 | — |
| +5 | K192058 | EV1000 Clinical Platform NI, EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2019 | 0 | — |
| +5 | K191272 | Wearable Device, Wearable Package | Current Health, Ltd. | 2019 | 16 | — |
| +5 | K190011 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019 | 0 | 2 |
| +5 | K180881 | HemoSphere Advanced Monitor, HemoSphere Pressure Cable | Edwards Lifesciences, LLC | 2018 | 40 | — |
| +5 | K173768 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2018 | 1 | — |
| +5 | K163381 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable | Edwards Lifesciences, LLC | 2017 | 41 | 2 |
| +5 | K153225 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2016 | 0 | — |
| +5 | K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Masimo Corporation | 2016 | 24 | — |
| +5 | K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2015 | 24 | — |
| +6 | K260880 | SedLine Sedation Monitor | Masimo Corporation | 2026 | 0 | — |
| +6 | K261098 | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN… | Senzime AB | 2026 | 0 | — |
| +6 | K252726 | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100… | Philips Medizin Systeme Boeblingen GmbH | 2026 | 0 | — |
| +6 | K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot… | Philips Medizin Systeme Böblingen GmbH | 2025 | 1 | — |
| +6 | K251146 | IntelliVue Patient monitors MX400, MX450, MX500, MX550 | Philips Medizin Systeme Boeblingen GmbH | 2025 | 0 | — |
| +6 | K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)… | Philips Medizin Systeme Böblingen GmbH | 2025 | 0 | — |
| +6 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere… | Edwards Lifesciences | 2025 | 2 | 1 |
| +6 | K242909 | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | Edwards Lifesciences, LLC | 2025 | 0 | — |
| +6 | K241066 | BB-613-BPM | Biobeat Technologies, Ltd. | 2025 | 0 | — |
| +6 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-… | Edwards Lifesciences | 2024 | 4 | — |
| +6 | K241397 | Hinscope | Hinlab Sas | 2024 | 0 | — |
| +6 | K233354 | WVSM Pro (Series) (500-0030-XX) | Athena Gtx, Inc. | 2024 | 0 | — |
| +6 | K231671 | IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)… | Philips Medizin Systeme Boeblingen GmbH | 2023 | 2 | — |
| +6 | K231035 | FusedCO Algorithm | Edwards Lifesciences, LLC | 2023 | 0 | — |
| +6 | K223332 | Task Force CORE | Cnsystems Medizintechnik GmbH | 2023 | 0 | — |
| +6 | K213863 | Everion+ System | Biofourmis Singapore Pte., Ltd. | 2023 | 1 | — |
| +6 | K211619 | Multi-Parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | 2022 | 0 | — |
| +6 | K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | 2022 | 7 | — |
| +6 | K221833 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module | Edwards Lifesciences, LLC | 2022 | 7 | — |
| +6 | K222550 | Current Health System | Current Health, Ltd. | 2022 | 1 | — |
| +6 | K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | 2021 | 8 | — |
| +6 | K203224 | Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform | Edwards Lifesciences, LLC | 2021 | 1 | — |
| +6 | K211465 | HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform | Edwards Lfesciences | 2021 | 15 | — |
| +6 | K203687 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction… | Edwards Lifesciences, LLC | 2021 | 18 | — |
| +6 | K203490 | FORE-SIGHT ELITE Absolute Tissue Oximeter | Edwards Lifesciences, LLC | 2021 | 0 | 1 |
| +6 | K201746 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies Limited | 2020 | 0 | 7 |
| +6 | K190205 | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | Edwards Lifesciences, LLC | 2019 | 34 | — |
| +6 | K191089 | Edwards Pressure Cable | Edwards Lifesciences, LLC | 2019 | 0 | — |
| +6 | K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2019 | 23 | — |
| +6 | K171121 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2017 | 16 | — |
| +6 | K170168 | Masimo Rad-97 and Accessories | Masimo Corporation | 2017 | 14 | — |
| +7 | K253654 | IntelliVue Measurement Rack 6000 (867317) | Philips Medizin Systeme Böblingen GmbH | 2026 | 0 | — |
| +7 | K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026 | 0 | — |
| +7 | K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | 2025 | 0 | — |
| +7 | K253034 | HemoSphere Stream Module | Edwards Lifesciences | 2025 | 0 | — |
| +7 | K241086 | Avidhrt Sense SpO2 | Avidhrt, Inc. | 2025 | 0 | — |
| +7 | K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. | 2024 | 0 | — |
| +7 | K232548 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2024 | 1 | — |
| +7 | K232915 | EpiMonitor | Empatica S.r.l. | 2024 | 1 | — |
| +7 | K214115 | MightySat -OTC | Masimo Corporation | 2024 | 1 | — |
| +7 | K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2023 | 4 | — |
| +7 | K230842 | SignalHF (IM008) | Implicity, Inc. | 2023 | 0 | — |
| +7 | K231506 | Current Health System | Current Health, Ltd. | 2023 | 0 | — |
| +7 | K230626 | Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services… | Ge Medical Systems Information Technologies, Inc. | 2023 | 2 | 1 |
| +7 | K231038 | Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences, LLC | 2023 | 6 | — |
| +7 | K230057 | Acumen Hypotension Prediction Index (HPI) Algorithm | Edwards Lifesciences, LLC | 2023 | 5 | — |
| +7 | K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable… | Edwards Lifesciences, LLC | 2022 | 14 | — |
| +7 | K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | 5 | — |
| +7 | K211400 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2022 | 0 | — |
| +7 | K211632 | Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102… | Shenzhen Narig Bio-Medical Technology Co., Ltd. | 2022 | 1 | — |
| +7 | K200717 | CLEWICU System (ClewICUServer and ClewICUnitor) | Clew Medical, Ltd. | 2021 | 12 | — |
| +7 | K200856 | SmartLinx Vitals Plus Patient Monitoring System | Capsule Technologie Sas | 2020 | 1 | — |
| +7 | K191882 | Masimo Centroid System | Masimo Corporation | 2020 | 3 | — |
| +7 | K193242 | Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and… | Masimo Corporation | 2020 | 7 | — |
| +7 | K180903 | 3880 MRI Patient Monitoring System | Iradimed Corporation | 2019 | 0 | — |
| +7 | K181352 | Loop System | Spry Health, Inc. | 2019 | 10 | — |
| +7 | K180046 | Masimo Rad-97 and Accessories | Masimo Corporation | 2018 | 13 | 1 |
| +8 | K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus… | Empatica S.r.l. | 2026 | 0 | — |
| +8 | K253417 | Masimo Root Monitoring System | Masimo Corporation | 2026 | 0 | — |
| +8 | K261367 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2026 | 0 | — |
| +8 | K252981 | EmbraceMini | Empatica S.r.l. | 2025 | 1 | — |
| +8 | K250515 | EpiMonitor | Empatica S.r.l. | 2025 | 0 | — |
| +8 | K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2025 | 0 | — |
| +8 | K242518 | Hypertension Prediction Index (HePI) Algorithm | Edwards Lifesciences, LLC | 2025 | 0 | — |
| +8 | K211498 | Nonin OTC Pulse Oximeter Model 3250 | Nonin Medical, Inc. | 2024 | 0 | — |
| +8 | K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024 | 2 | — |
| +8 | K241758 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse… | Stryker Sustainability Solutions | 2024 | 0 | — |
| +8 | K240236 | Happy Ring Health Monitoring System | Happy Health, Inc. | 2024 | 0 | — |
| +8 | K233253 | eCARTv5 Clinical Deterioration Suite (“eCART”) | Agilemd, Inc. | 2024 | 1 | — |
| +8 | K240251 | ANNE Chest | Sibel Health, Inc. | 2024 | 0 | — |
| +8 | K232445 | CSF-4 (CSF-4) | Cardiacsense | 2024 | 0 | — |
| +8 | K234130 | Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application… | Ge Medical Systems Information Technologies, Inc. | 2024 | 0 | 4 |
| +8 | K233216 | CLEWICU System | Clew Medical, Ltd. | 2024 | 0 | — |
| +8 | K223865 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid… | Edwards Lifesciences, LLC | 2023 | 7 | — |
| +8 | K223498 | Radius VSM and Accessories | Masimo Corporation | 2023 | 1 | 2 |
| +8 | K223651 | Cerebral Adaptive Index (CAI) Algorithm | Edwards Lifesciences, LLC | 2023 | 6 | — |
| +8 | K212161 | Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories | Masimo Corporation | 2023 | 0 | — |
| +8 | K222213 | Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103… | Unimed Medical Supplies, Inc. | 2022 | 0 | — |