Devices descending from K031330
519 later devices reach Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop… through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +7 | K231506 | Current Health System | Current Health, Ltd. | 2023 | 0 | — |
| +7 | K223865 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid… | Edwards Lifesciences, LLC | 2023 | 7 | — |
| +7 | K223651 | Cerebral Adaptive Index (CAI) Algorithm | Edwards Lifesciences, LLC | 2023 | 6 | — |
| +7 | K211619 | Multi-Parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | 2022 | 0 | — |
| +7 | K221833 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module | Edwards Lifesciences, LLC | 2022 | 7 | — |
| +7 | K212473 | Welch Allyn Connex Central Station | Welch Allyn, Inc. | 2022 | 0 | — |
| +7 | K220308 | Patient Monitor: RespArray | Edan Instruments, Inc. | 2022 | 1 | — |
| +7 | K213911 | Microstream CO2 NanoPod | Covidien, LLC | 2022 | 0 | — |
| +7 | K213518 | CARESCAPE CO2 Microstream parameter | Covidien, LLC | 2022 | 0 | — |
| +7 | K212219 | AHI System | Fifth Eye, Inc. | 2021 | 1 | — |
| +7 | K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X) | Philips Medizin Systeme Boeblingen GmbH | 2021 | 0 | — |
| +7 | K203224 | Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform | Edwards Lifesciences, LLC | 2021 | 1 | — |
| +7 | K211465 | HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform | Edwards Lfesciences | 2021 | 15 | — |
| +7 | K201635 | MouthLab Vital Signs Monitoring System | Multisensor Diagnostics (Dba Aidar Health) | 2021 | 0 | — |
| +7 | K202336 | Patient Monitor | Edan Instruments, Inc. | 2021 | 3 | 1 |
| +7 | K202189 | Graffiti | Ge Medical Systems Information Technologies, Inc. | 2020 | 0 | — |
| +7 | K201746 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies Limited | 2020 | 0 | 7 |
| +7 | K201432 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2020 | 2 | — |
| +7 | K200594 | Capnostream 35 Portable Respiratory Monitor | Oridion Medical 1987, Ltd. | 2020 | 1 | — |
| +7 | K190270 | FORE-SIGHT ELITE Tissue Oximeter Module | Cas Medical Systems, Inc. | 2019 | 15 | — |
| +7 | K190090 | DynoSense Vital Sign Measuring System | Dynosense Corp. | 2019 | 0 | — |
| +7 | K190130 | The ClearSight finger cuffs | Edwards Lifesciences, LLC | 2019 | 29 | — |
| +7 | K180482 | ZOLL Propaq M | ZOLL Medical Corporation | 2018 | 2 | — |
| +7 | K182245 | EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight… | Edwards Lifesciences, LLC | 2018 | 30 | — |
| +7 | K173181 | ExSpiron 1Xi | Respiratory Motion, Inc. | 2018 | 2 | — |
| +7 | K172890 | SedLine Sedation Monitor | Masimo Corporation | 2018 | 5 | — |
| +7 | K171901 | uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017 | 0 | — |
| +7 | K171423 | Nasal Alar SpO2 Sensor | Xhale, Inc. | 2017 | 1 | 1 |
| +7 | K163649 | SureSigns VS3; SureSigns VS4 | Philips Medical Systems | 2017 | 1 | 10 |
| +7 | K160746 | CARDIOLINE touchECG | Cardioline S.P.A | 2016 | 0 | — |
| +7 | K153046 | Hamilton-MR1 | Hamilton Medical AG | 2016 | 0 | Class I |
| +7 | K153702 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2016 | 3 | 12 |
| +7 | K160552 | EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000… | Edwards Lifesciences, LLC | 2016 | 51 | Class I |
| +7 | K160951 | Philips Efficia CMS200 Central Monitoring System | Philips Medical Systems | 2016 | 0 | 1 |
| +7 | K142356 | Connex Spot Monitor,901058 Vital Signs Monitor Core | Welch Allyn, Inc. | 2014 | 1 | 3 |
| +7 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | 51 | — |
| +7 | K141774 | Zoll X Series | ZOLL Medical Corporation | 2014 | 2 | — |
| +7 | K111403 | Masimo Rainbow Set Pronto-7 Pulse CO-Oximeter and Accessories | Masimo Corporation | 2011 | 0 | — |
| +8 | K260008 | Deterioration Index Version 2 | Epic Systems Corporation | 2026 | 0 | — |
| +8 | K260226 | ElintMAX Respiratory Monitor (ElintMAX Monitor A1) | Amptron Medical, Inc. | 2026 | 0 | — |
| +8 | K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus… | Empatica S.r.l. | 2026 | 0 | — |
| +8 | K260211 | Dashboard (P007000) | Hill-Rom, Inc. | 2026 | 0 | — |
| +8 | K261367 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2026 | 0 | — |
| +8 | K251326 | Respiration Rate algorithm | Edwards Lifesciences, LLC | 2026 | 0 | — |
| +8 | K253887 | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar… | Philips Medizin Systeme | 2026 | 0 | — |
| +8 | K253030 | Capnostream™35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC | 2026 | 0 | — |
| +8 | K250349 | Vista CMS | Shanghai Draeger Medical Instrument Co., Ltd. | 2026 | 0 | — |
| +8 | K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026 | 0 | — |
| +8 | K252981 | EmbraceMini | Empatica S.r.l. | 2025 | 1 | — |
| +8 | K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | 2025 | 0 | — |
| +8 | K253034 | HemoSphere Stream Module | Edwards Lifesciences | 2025 | 0 | — |
| +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 | K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | Welch Allyn, Inc. | 2024 | 0 | 1 |
| +8 | K240596 | Cerebral Autoregulation Index (CAI) Algorithm | Edwards Lifesciences | 2024 | 0 | — |
| +8 | K240236 | Happy Ring Health Monitoring System | Happy Health, Inc. | 2024 | 0 | — |
| +8 | K233984 | Acumen Assisted Fluid Management (AFM) Software Feature | Edwards Lifesciences, LLC | 2024 | 0 | — |
| +8 | K240320 | Patient Monitor (RespArray) | Edan Instruments, Inc. | 2024 | 0 | — |
| +8 | K232962 | Patient Monitor (iX10, iX12, iX15) | Edan Instruments, Inc. | 2024 | 2 | 1 |
| +8 | K230842 | SignalHF (IM008) | Implicity, Inc. | 2023 | 0 | — |
| +8 | K230919 | Acumen IQ finger cuff | Edwards Lifesciences, LLC | 2023 | 3 | — |
| +8 | K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced… | Edwards Lifesciencess, LLC | 2023 | 6 | 2 |
| +8 | K222010 | Biobeat Platform-2 and BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | 1 | — |
| +8 | K221203 | AHI System | Fifth Eye, Inc. | 2022 | 0 | — |
| +8 | K214072 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2022 | 1 | — |
| +8 | K203113 | Masimo SedLine Sedation Monitor and Accessories | Masimo Corporation | 2022 | 1 | — |
| +8 | K202375 | ZOLL Propaq M | ZOLL Medical Corporation | 2021 | 1 | — |
| +8 | K193179 | EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2019 | 0 | — |
| +8 | K192595 | ExSpiron 2Xi | Respiratory Motion | 2019 | 0 | — |
| +8 | K183521 | CNAP Monitor | Cnsystems Medizintechnik GmbH | 2019 | 1 | — |
| +8 | K192058 | EV1000 Clinical Platform NI, EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2019 | 0 | — |
| +8 | K163584 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2017 | 2 | — |
| +8 | K163381 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable | Edwards Lifesciences, LLC | 2017 | 41 | 2 |
| +8 | K153225 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2016 | 0 | — |
| +8 | K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Masimo Corporation | 2016 | 24 | — |
| +8 | K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2015 | 24 | — |
| +9 | K260880 | SedLine Sedation Monitor | Masimo Corporation | 2026 | 0 | — |
| +9 | K252250 | Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model… | Shanghai Draeger Medical Instrument Co., Ltd. | 2026 | 0 | — |
| +9 | K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | Edan Instruments, Inc. | 2025 | 0 | — |
| +9 | K243324 | Masimo O3 Regional Oximeter | Masimo Corporation | 2025 | 0 | — |
| +9 | K242909 | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | Edwards Lifesciences, LLC | 2025 | 0 | — |
| +9 | K241066 | BB-613-BPM | Biobeat Technologies, Ltd. | 2025 | 0 | — |
| +9 | K233354 | WVSM Pro (Series) (500-0030-XX) | Athena Gtx, Inc. | 2024 | 0 | — |
| +9 | K223332 | Task Force CORE | Cnsystems Medizintechnik GmbH | 2023 | 0 | — |
| +9 | K183387 | M3290B Patient Information Center iX | Philips Medical Systems | 2019 | 0 | — |
| +9 | K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2019 | 23 | — |
| +9 | K173203 | Athena GTX Device Management Suite (ADMS) Software | Athena Gtx | 2018 | 0 | — |
| +9 | K171121 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2017 | 16 | — |
| +9 | K170168 | Masimo Rad-97 and Accessories | Masimo Corporation | 2017 | 14 | — |
| +10 | K241086 | Avidhrt Sense SpO2 | Avidhrt, Inc. | 2025 | 0 | — |
| +10 | K214115 | MightySat -OTC | Masimo Corporation | 2024 | 1 | — |
| +10 | K230626 | Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services… | Ge Medical Systems Information Technologies, Inc. | 2023 | 2 | 1 |
| +10 | K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | 5 | — |
| +10 | K211400 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2022 | 0 | — |
| +10 | 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 | — |
| +10 | K200856 | SmartLinx Vitals Plus Patient Monitoring System | Capsule Technologie Sas | 2020 | 1 | — |
| +10 | K191882 | Masimo Centroid System | Masimo Corporation | 2020 | 3 | — |
| +10 | K193242 | Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and… | Masimo Corporation | 2020 | 7 | — |
| +10 | K181352 | Loop System | Spry Health, Inc. | 2019 | 10 | — |
| +10 | K180046 | Masimo Rad-97 and Accessories | Masimo Corporation | 2018 | 13 | 1 |