Devices descending from K100428
115 later devices reach Masimo Rainbow Set Radical 7R Pulse CO-Oximeter through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K151812 | Patient Monitors Various Models | Philips Medical Systems | 2016 | 0 | — |
| +1 | K150030 | Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor | Fukuda Denshi USA, Inc. | 2015 | 0 | — |
| +1 | K133961 | Suresigns VS3, Suresigns VS4 | Philips Medical Systems | 2014 | 3 | — |
| +1 | K124041 | NBM-200MP | Orsense, Ltd. | 2013 | 1 | — |
| +1 | K121013 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2012 | 65 | — |
| +1 | K112432 | Zoll X Series | Zoll Medical Corporation, World Wide Headquarters | 2012 | 8 | 2 |
| +1 | K110516 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | 67 | — |
| +1 | K110028 | Masimo Radical Y Pulse CO-Oximeter | Masimo Corporation | 2011 | 89 | — |
| +2 | K190624 | EarlyVue VS30 | Philips Medizin Systeme Boeblingen GmbH | 2019 | 0 | 3 |
| +2 | K183687 | LifeWindow LW8 Lite | Digicare Biomedical Technology, Inc. | 2019 | 1 | — |
| +2 | K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System… | Welch Allyn, Inc. | 2017 | 2 | 3 |
| +2 | K161909 | IQvitals Zone | Midmark Corporation | 2016 | 1 | 4 |
| +2 | K152043 | Diagnostic Station DS20 | Schiller AG | 2016 | 1 | — |
| +2 | K151761 | SureSigns VS3, SureSigns VS4 | Phillips Medical Systems | 2015 | 2 | — |
| +2 | K142209 | Pulse oximeter NBM-200 | Orsense, Ltd. | 2015 | 0 | — |
| +2 | K142915 | ZOLL X Series | ZOLL Medical Corporation | 2014 | 0 | — |
| +2 | K133810 | VC150 Vital Signs Monitor | Innokas Yhtyma | 2014 | 3 | 3 |
| +2 | K133484 | Zoll X Series | Zoll Medical Corp | 2014 | 1 | — |
| +2 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | 58 | — |
| +2 | K133269 | Zoll X Series | Zoll Medical Corporation, World Wide Headquarters | 2014 | 4 | — |
| +2 | K133988 | Tempus Pro Extended Features | Remote Diagnostic Technologies, Ltd. | 2014 | 3 | — |
| +2 | K132808 | Vital Signs Monitor, Connex Vital Signs Monitor | Welch Allyn, Inc. | 2013 | 6 | — |
| +2 | K121367 | Zoll Propaq XM | ZOLL Medical Corporation | 2012 | 3 | 1 |
| +2 | K113798 | Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set | Draeger Medical Systems, Inc. | 2012 | 23 | 8 |
| +2 | K112687 | Connex (R) Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | 66 | — |
| +3 | K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | Midmark Corporation | 2026 | 0 | — |
| +3 | K233810 | Portrait VSM | Ge Medical Systems Information Technologies, Inc. | 2024 | 0 | 1 |
| +3 | K212473 | Welch Allyn Connex Central Station | Welch Allyn, Inc. | 2022 | 0 | — |
| +3 | K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2022 | 2 | 6 |
| +3 | K203088 | Infinity Acute Care System (IACS) Monitoring System | Draeger Medical Systems, Inc. | 2022 | 1 | 1 |
| +3 | K201764 | Infinity Acute Care System (IACS) Monitoring Solution | Draeger Medical Systems, Inc. | 2021 | 2 | — |
| +3 | K201635 | MouthLab Vital Signs Monitoring System | Multisensor Diagnostics (Dba Aidar Health) | 2021 | 0 | — |
| +3 | K200434 | V20, V20a, AVSM3 SNF | Mediana Co., Ltd. | 2020 | 0 | 1 |
| +3 | K190090 | DynoSense Vital Sign Measuring System | Dynosense Corp. | 2019 | 0 | — |
| +3 | K190073 | Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case… | Current Health, Ltd. | 2019 | 18 | — |
| +3 | K180482 | ZOLL Propaq M | ZOLL Medical Corporation | 2018 | 2 | — |
| +3 | K182543 | Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device… | Snap40, Ltd. | 2018 | 19 | — |
| +3 | K172890 | SedLine Sedation Monitor | Masimo Corporation | 2018 | 5 | — |
| +3 | K170182 | Cardiovit FT-1 | Schiller AG | 2017 | 0 | — |
| +3 | K170567 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2017 | 2 | — |
| +3 | K163649 | SureSigns VS3; SureSigns VS4 | Philips Medical Systems | 2017 | 1 | 10 |
| +3 | K142356 | Connex Spot Monitor,901058 Vital Signs Monitor Core | Welch Allyn, Inc. | 2014 | 1 | 3 |
| +3 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | 51 | — |
| +3 | K141774 | Zoll X Series | ZOLL Medical Corporation | 2014 | 2 | — |
| +4 | K260579 | Infinity® Acute Care System (IACS) – VG8.1 | Draeger Medical Systems, Inc. | 2026 | 0 | — |
| +4 | K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2025 | 0 | — |
| +4 | K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | Welch Allyn, Inc. | 2024 | 0 | 1 |
| +4 | K223574 | IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)… | Philips Medizin Systeme Boeblingen GmbH | 2023 | 2 | — |
| +4 | K203113 | Masimo SedLine Sedation Monitor and Accessories | Masimo Corporation | 2022 | 1 | — |
| +4 | K202375 | ZOLL Propaq M | ZOLL Medical Corporation | 2021 | 1 | — |
| +4 | K192952 | Spire Health Remote Patient Monitoring System | Spire, Inc. D/B/A Spire Health | 2020 | 0 | — |
| +4 | K191272 | Wearable Device, Wearable Package | Current Health, Ltd. | 2019 | 16 | — |
| +4 | K173768 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2018 | 1 | — |
| +4 | K153225 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2016 | 0 | — |
| +4 | K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Masimo Corporation | 2016 | 24 | — |
| +4 | K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2015 | 24 | — |
| +5 | K260880 | SedLine Sedation Monitor | Masimo Corporation | 2026 | 0 | — |
| +5 | K251146 | IntelliVue Patient monitors MX400, MX450, MX500, MX550 | Philips Medizin Systeme Boeblingen GmbH | 2025 | 0 | — |
| +5 | K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)… | Philips Medizin Systeme Böblingen GmbH | 2025 | 0 | — |
| +5 | K241397 | Hinscope | Hinlab Sas | 2024 | 0 | — |
| +5 | K233354 | WVSM Pro (Series) (500-0030-XX) | Athena Gtx, Inc. | 2024 | 0 | — |
| +5 | K213863 | Everion+ System | Biofourmis Singapore Pte., Ltd. | 2023 | 1 | — |
| +5 | K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | 2022 | 7 | — |
| +5 | K222550 | Current Health System | Current Health, Ltd. | 2022 | 1 | — |
| +5 | K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | 2021 | 8 | — |
| +5 | K201746 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies Limited | 2020 | 0 | 7 |
| +5 | K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2019 | 23 | — |
| +5 | K171121 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2017 | 16 | — |
| +5 | K170168 | Masimo Rad-97 and Accessories | Masimo Corporation | 2017 | 14 | — |
| +6 | K241086 | Avidhrt Sense SpO2 | Avidhrt, Inc. | 2025 | 0 | — |
| +6 | K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. | 2024 | 0 | — |
| +6 | K232548 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2024 | 1 | — |
| +6 | K232915 | EpiMonitor | Empatica S.r.l. | 2024 | 1 | — |
| +6 | K214115 | MightySat -OTC | Masimo Corporation | 2024 | 1 | — |
| +6 | K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2023 | 4 | — |
| +6 | K231506 | Current Health System | Current Health, Ltd. | 2023 | 0 | — |
| +6 | K230626 | Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services… | Ge Medical Systems Information Technologies, Inc. | 2023 | 2 | 1 |
| +6 | K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | 5 | — |
| +6 | K211400 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2022 | 0 | — |
| +6 | 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 | — |
| +6 | K200856 | SmartLinx Vitals Plus Patient Monitoring System | Capsule Technologie Sas | 2020 | 1 | — |
| +6 | K191882 | Masimo Centroid System | Masimo Corporation | 2020 | 3 | — |
| +6 | K193242 | Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and… | Masimo Corporation | 2020 | 7 | — |
| +6 | K180903 | 3880 MRI Patient Monitoring System | Iradimed Corporation | 2019 | 0 | — |
| +6 | K181352 | Loop System | Spry Health, Inc. | 2019 | 10 | — |
| +6 | K180046 | Masimo Rad-97 and Accessories | Masimo Corporation | 2018 | 13 | 1 |
| +7 | K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus… | Empatica S.r.l. | 2026 | 0 | — |
| +7 | K253417 | Masimo Root Monitoring System | Masimo Corporation | 2026 | 0 | — |
| +7 | K261367 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2026 | 0 | — |
| +7 | K252981 | EmbraceMini | Empatica S.r.l. | 2025 | 1 | — |
| +7 | K250515 | EpiMonitor | Empatica S.r.l. | 2025 | 0 | — |
| +7 | K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2025 | 0 | — |
| +7 | K211498 | Nonin OTC Pulse Oximeter Model 3250 | Nonin Medical, Inc. | 2024 | 0 | — |
| +7 | K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024 | 2 | — |
| +7 | K241758 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse… | Stryker Sustainability Solutions | 2024 | 0 | — |
| +7 | K240236 | Happy Ring Health Monitoring System | Happy Health, Inc. | 2024 | 0 | — |
| +7 | K240251 | ANNE Chest | Sibel Health, Inc. | 2024 | 0 | — |
| +7 | K232445 | CSF-4 (CSF-4) | Cardiacsense | 2024 | 0 | — |
| +7 | K234130 | Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application… | Ge Medical Systems Information Technologies, Inc. | 2024 | 0 | 4 |
| +7 | K223498 | Radius VSM and Accessories | Masimo Corporation | 2023 | 1 | 2 |