Devices descending from K040214
254 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 |
|---|---|---|---|---|---|---|
| +5 | K140312 | EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM System | Edwards Lifesciences, LLC | 2014 | 52 | 1 |
| +5 | K133269 | Zoll X Series | Zoll Medical Corporation, World Wide Headquarters | 2014 | 4 | — |
| +5 | K133988 | Tempus Pro Extended Features | Remote Diagnostic Technologies, Ltd. | 2014 | 3 | — |
| +5 | K132808 | Vital Signs Monitor, Connex Vital Signs Monitor | Welch Allyn, Inc. | 2013 | 6 | — |
| +5 | K121367 | Zoll Propaq XM | ZOLL Medical Corporation | 2012 | 3 | 1 |
| +5 | K113798 | Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set | Draeger Medical Systems, Inc. | 2012 | 23 | 8 |
| +5 | K100403 | Masimo Rainbow Set Pronto -7 Pulse CO- Oximeter and Accessories, Model Pronto-7 | Masimo Corporation | 2010 | 1 | 1 |
| +5 | K100617 | Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20D | Masimo Corporation | 2010 | 39 | — |
| +6 | K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | Midmark 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 | 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 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-… | Edwards Lifesciences | 2024 | 4 | — |
| +6 | K233810 | Portrait VSM | Ge Medical Systems Information Technologies, Inc. | 2024 | 0 | 1 |
| +6 | K231671 | IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)… | Philips Medizin Systeme Boeblingen GmbH | 2023 | 2 | — |
| +6 | K211619 | Multi-Parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | 2022 | 0 | — |
| +6 | K212473 | Welch Allyn Connex Central Station | Welch Allyn, Inc. | 2022 | 0 | — |
| +6 | K213911 | Microstream CO2 NanoPod | Covidien, LLC | 2022 | 0 | — |
| +6 | K213518 | CARESCAPE CO2 Microstream parameter | Covidien, LLC | 2022 | 0 | — |
| +6 | K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2022 | 2 | 6 |
| +6 | K203088 | Infinity Acute Care System (IACS) Monitoring System | Draeger Medical Systems, Inc. | 2022 | 1 | 1 |
| +6 | K201764 | Infinity Acute Care System (IACS) Monitoring Solution | Draeger Medical Systems, Inc. | 2021 | 2 | — |
| +6 | K201635 | MouthLab Vital Signs Monitoring System | Multisensor Diagnostics (Dba Aidar Health) | 2021 | 0 | — |
| +6 | K200434 | V20, V20a, AVSM3 SNF | Mediana Co., Ltd. | 2020 | 0 | 1 |
| +6 | K200594 | Capnostream 35 Portable Respiratory Monitor | Oridion Medical 1987, Ltd. | 2020 | 1 | — |
| +6 | K190090 | DynoSense Vital Sign Measuring System | Dynosense Corp. | 2019 | 0 | — |
| +6 | K190130 | The ClearSight finger cuffs | Edwards Lifesciences, LLC | 2019 | 29 | — |
| +6 | K190073 | Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case… | Current Health, Ltd. | 2019 | 18 | — |
| +6 | K180482 | ZOLL Propaq M | ZOLL Medical Corporation | 2018 | 2 | — |
| +6 | K182245 | EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight… | Edwards Lifesciences, LLC | 2018 | 30 | — |
| +6 | K182543 | Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device… | Snap40, Ltd. | 2018 | 19 | — |
| +6 | K172890 | SedLine Sedation Monitor | Masimo Corporation | 2018 | 5 | — |
| +6 | K170182 | Cardiovit FT-1 | Schiller AG | 2017 | 0 | — |
| +6 | K170567 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2017 | 2 | — |
| +6 | K163649 | SureSigns VS3; SureSigns VS4 | Philips Medical Systems | 2017 | 1 | 10 |
| +6 | K160552 | EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000… | Edwards Lifesciences, LLC | 2016 | 51 | Class I |
| +6 | K142356 | Connex Spot Monitor,901058 Vital Signs Monitor Core | Welch Allyn, Inc. | 2014 | 1 | 3 |
| +6 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | 51 | — |
| +6 | K141774 | Zoll X Series | ZOLL Medical Corporation | 2014 | 2 | — |
| +6 | K111403 | Masimo Rainbow Set Pronto-7 Pulse CO-Oximeter and Accessories | Masimo Corporation | 2011 | 0 | — |
| +6 | K111621 | Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry Sensors | Masimo Corporation | 2011 | 38 | — |
| +7 | K260579 | Infinity® Acute Care System (IACS) – VG8.1 | Draeger Medical Systems, Inc. | 2026 | 0 | — |
| +7 | K253030 | Capnostream™35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC | 2026 | 0 | — |
| +7 | K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | 2025 | 0 | — |
| +7 | K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot… | Philips Medizin Systeme Böblingen GmbH | 2025 | 1 | — |
| +7 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere… | Edwards Lifesciences | 2025 | 2 | 1 |
| +7 | K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2025 | 0 | — |
| +7 | K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | Welch Allyn, Inc. | 2024 | 0 | 1 |
| +7 | K230919 | Acumen IQ finger cuff | Edwards Lifesciences, LLC | 2023 | 3 | — |
| +7 | K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced… | Edwards Lifesciencess, LLC | 2023 | 6 | 2 |
| +7 | K222010 | Biobeat Platform-2 and BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | 1 | — |
| +7 | K203113 | Masimo SedLine Sedation Monitor and Accessories | Masimo Corporation | 2022 | 1 | — |
| +7 | K202375 | ZOLL Propaq M | ZOLL Medical Corporation | 2021 | 1 | — |
| +7 | K203131 | EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2021 | 0 | — |
| +7 | K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | Edwards Lifesiences, LLC | 2020 | 27 | 1 |
| +7 | K192952 | Spire Health Remote Patient Monitoring System | Spire, Inc. D/B/A Spire Health | 2020 | 0 | — |
| +7 | K193179 | EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2019 | 0 | — |
| +7 | K183521 | CNAP Monitor | Cnsystems Medizintechnik GmbH | 2019 | 1 | — |
| +7 | K192058 | EV1000 Clinical Platform NI, EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2019 | 0 | — |
| +7 | K191272 | Wearable Device, Wearable Package | Current Health, Ltd. | 2019 | 16 | — |
| +7 | K180881 | HemoSphere Advanced Monitor, HemoSphere Pressure Cable | Edwards Lifesciences, LLC | 2018 | 40 | — |
| +7 | K173768 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2018 | 1 | — |
| +7 | K163381 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable | Edwards Lifesciences, LLC | 2017 | 41 | 2 |
| +7 | K153225 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2016 | 0 | — |
| +7 | K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Masimo Corporation | 2016 | 24 | — |
| +7 | K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2015 | 24 | — |
| +8 | K260880 | SedLine Sedation Monitor | Masimo Corporation | 2026 | 0 | — |
| +8 | K253654 | IntelliVue Measurement Rack 6000 (867317) | Philips Medizin Systeme Böblingen GmbH | 2026 | 0 | — |
| +8 | K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026 | 0 | — |
| +8 | K253034 | HemoSphere Stream Module | Edwards Lifesciences | 2025 | 0 | — |
| +8 | K242909 | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | Edwards Lifesciences, LLC | 2025 | 0 | — |
| +8 | K241066 | BB-613-BPM | Biobeat Technologies, Ltd. | 2025 | 0 | — |
| +8 | K241397 | Hinscope | Hinlab Sas | 2024 | 0 | — |
| +8 | K233354 | WVSM Pro (Series) (500-0030-XX) | Athena Gtx, Inc. | 2024 | 0 | — |
| +8 | K231035 | FusedCO Algorithm | Edwards Lifesciences, LLC | 2023 | 0 | — |
| +8 | K223332 | Task Force CORE | Cnsystems Medizintechnik GmbH | 2023 | 0 | — |
| +8 | K213863 | Everion+ System | Biofourmis Singapore Pte., Ltd. | 2023 | 1 | — |
| +8 | K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | 2022 | 7 | — |
| +8 | K221833 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module | Edwards Lifesciences, LLC | 2022 | 7 | — |
| +8 | K222550 | Current Health System | Current Health, Ltd. | 2022 | 1 | — |
| +8 | K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | 2021 | 8 | — |
| +8 | K203224 | Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform | Edwards Lifesciences, LLC | 2021 | 1 | — |
| +8 | K211465 | HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform | Edwards Lfesciences | 2021 | 15 | — |
| +8 | K203687 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction… | Edwards Lifesciences, LLC | 2021 | 18 | — |
| +8 | K203490 | FORE-SIGHT ELITE Absolute Tissue Oximeter | Edwards Lifesciences, LLC | 2021 | 0 | 1 |
| +8 | K201746 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies Limited | 2020 | 0 | 7 |
| +8 | K190205 | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | Edwards Lifesciences, LLC | 2019 | 34 | — |
| +8 | K191089 | Edwards Pressure Cable | Edwards Lifesciences, LLC | 2019 | 0 | — |
| +8 | K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2019 | 23 | — |
| +8 | K171121 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2017 | 16 | — |
| +8 | K170168 | Masimo Rad-97 and Accessories | Masimo Corporation | 2017 | 14 | — |
| +9 | K241086 | Avidhrt Sense SpO2 | Avidhrt, Inc. | 2025 | 0 | — |
| +9 | K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. | 2024 | 0 | — |
| +9 | K232548 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2024 | 1 | — |
| +9 | K232915 | EpiMonitor | Empatica S.r.l. | 2024 | 1 | — |
| +9 | K214115 | MightySat -OTC | Masimo Corporation | 2024 | 1 | — |
| +9 | K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2023 | 4 | — |
| +9 | K230842 | SignalHF (IM008) | Implicity, Inc. | 2023 | 0 | — |
| +9 | K231506 | Current Health System | Current Health, Ltd. | 2023 | 0 | — |