Devices descending from K103604
91 later devices reach Isa CO2, Isa AX+, Isa or+ through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | 58 | — |
| +1 | K140430 | 740 Select | Cas Medical Systems, Inc. | 2014 | 1 | — |
| +1 | K123043 | Irma C02 Model 200101; Irma AX 200601 | Phasein AB | 2012 | 11 | — |
| +1 | K120173 | Patient Monitor | Edan Instruments, Inc. | 2012 | 10 | — |
| +1 | K113623 | Patient Monitor | Edan Instruments, Inc. | 2012 | 15 | 2 |
| +2 | K250148 | Medical Gas Analyzer (AG200) | Prior Care Science Technology, Ltd. | 2025 | 0 | — |
| +2 | K221879 | Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 | Caf Medical Solutions, Inc. | 2022 | 0 | — |
| +2 | K172890 | SedLine Sedation Monitor | Masimo Corporation | 2018 | 5 | — |
| +2 | K160981 | Patient Monitor | Edan Instruments, Inc. | 2016 | 8 | 1 |
| +2 | K150620 | 740 Select | Cas Medical Systems, Inc. | 2015 | 0 | 1 |
| +2 | K140264 | MADM | Thornhill Research, Inc. | 2015 | 0 | — |
| +2 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | 51 | — |
| +2 | K132077 | Patient Monitor | Advanced Instrumentations, Inc. | 2014 | 0 | — |
| +2 | K131971 | IM60/IM70 Patient Monitor | Edan Instruments, Inc. | 2014 | 14 | 2 |
| +2 | K123144 | VIVO 50 | Ge Healthcare, Breas Medical AB | 2013 | 8 | 1 |
| +3 | K223574 | IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)… | Philips Medizin Systeme Boeblingen GmbH | 2023 | 2 | — |
| +3 | K221616 | Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17 | Caf Medical Solutions, Inc. | 2022 | 0 | — |
| +3 | K203113 | Masimo SedLine Sedation Monitor and Accessories | Masimo Corporation | 2022 | 1 | — |
| +3 | K192514 | Patient Monitor | Edan Instruments, Inc. | 2020 | 6 | 1 |
| +3 | K161056 | Telemetry Transmitter | Edan Instruments, Inc. | 2017 | 0 | 2 |
| +3 | K160481 | Vivo 60 | Breas Medical AB | 2016 | 7 | 2 |
| +3 | K153225 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2016 | 0 | — |
| +3 | K152552 | Patient Monitor | Edan Instruments, Inc. | 2016 | 2 | 1 |
| +3 | K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Masimo Corporation | 2016 | 24 | — |
| +3 | K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2015 | 24 | — |
| +4 | K260880 | SedLine Sedation Monitor | Masimo Corporation | 2026 | 0 | — |
| +4 | K251146 | IntelliVue Patient monitors MX400, MX450, MX500, MX550 | Philips Medizin Systeme Boeblingen GmbH | 2025 | 0 | — |
| +4 | K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)… | Philips Medizin Systeme Böblingen GmbH | 2025 | 0 | — |
| +4 | K220308 | Patient Monitor: RespArray | Edan Instruments, Inc. | 2022 | 1 | — |
| +4 | K193586 | Vivo 45 LS | Breas Medical AB | 2021 | 2 | Class I |
| +4 | K202336 | Patient Monitor | Edan Instruments, Inc. | 2021 | 3 | 1 |
| +4 | K181170 | Trilogy Evo Universal | Respironics, Inc. | 2019 | 0 | Class I |
| +4 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | 5 | Class I |
| +4 | K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2019 | 23 | — |
| +4 | K173042 | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models… | Edan Instruments, Inc. | 2018 | 1 | 2 |
| +4 | K171121 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2017 | 16 | — |
| +4 | K170168 | Masimo Rad-97 and Accessories | Masimo Corporation | 2017 | 14 | — |
| +5 | K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | 2025 | 0 | — |
| +5 | K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | Edan Instruments, Inc. | 2025 | 0 | — |
| +5 | K241086 | Avidhrt Sense SpO2 | Avidhrt, Inc. | 2025 | 0 | — |
| +5 | K233452 | Vivo 45 LS | Breas Medical AB | 2025 | 0 | 1 |
| +5 | K241135 | RESPOND (R) Ventilator | Corvent Medical, Inc. | 2024 | 0 | — |
| +5 | K240807 | VM-2000 | Ventis Medical, Inc. | 2024 | 0 | — |
| +5 | K240320 | Patient Monitor (RespArray) | Edan Instruments, Inc. | 2024 | 0 | — |
| +5 | K232962 | Patient Monitor (iX10, iX12, iX15) | Edan Instruments, Inc. | 2024 | 2 | 1 |
| +5 | K214115 | MightySat -OTC | Masimo Corporation | 2024 | 1 | — |
| +5 | K230626 | Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services… | Ge Medical Systems Information Technologies, Inc. | 2023 | 2 | 1 |
| +5 | K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | 5 | — |
| +5 | K211400 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2022 | 0 | — |
| +5 | 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 | — |
| +5 | K200856 | SmartLinx Vitals Plus Patient Monitoring System | Capsule Technologie Sas | 2020 | 1 | — |
| +5 | K191882 | Masimo Centroid System | Masimo Corporation | 2020 | 3 | — |
| +5 | K193242 | Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and… | Masimo Corporation | 2020 | 7 | — |
| +5 | K180903 | 3880 MRI Patient Monitoring System | Iradimed Corporation | 2019 | 0 | — |
| +5 | K181352 | Loop System | Spry Health, Inc. | 2019 | 10 | — |
| +5 | K180046 | Masimo Rad-97 and Accessories | Masimo Corporation | 2018 | 13 | 1 |
| +6 | K253417 | Masimo Root Monitoring System | Masimo Corporation | 2026 | 0 | — |
| +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 | 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 | — |
| +6 | K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | Edan Instruments, Inc. | 2025 | 0 | — |
| +6 | K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | Welch Allyn, Inc. | 2024 | 0 | 1 |
| +6 | K211498 | Nonin OTC Pulse Oximeter Model 3250 | Nonin Medical, Inc. | 2024 | 0 | — |
| +6 | K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024 | 2 | — |
| +6 | K241758 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse… | Stryker Sustainability Solutions | 2024 | 0 | — |
| +6 | K240251 | ANNE Chest | Sibel Health, Inc. | 2024 | 0 | — |
| +6 | K232445 | CSF-4 (CSF-4) | Cardiacsense | 2024 | 0 | — |
| +6 | K234130 | Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application… | Ge Medical Systems Information Technologies, Inc. | 2024 | 0 | 4 |
| +6 | K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2023 | 4 | — |
| +6 | K223498 | Radius VSM and Accessories | Masimo Corporation | 2023 | 1 | 2 |
| +6 | K212161 | Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories | Masimo Corporation | 2023 | 0 | — |
| +6 | K222010 | Biobeat Platform-2 and BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | 1 | — |
| +6 | 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 | — |
| +6 | K222019 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse… | Stryker Sustainability Solutions | 2022 | 1 | — |
| +6 | K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | 2022 | 7 | — |
| +6 | K220351 | Polso Watch | Chronisense Medical, Ltd. | 2022 | 0 | — |
| +6 | K210204 | Capsule Vitals Plus Patient Monitoring System | Capsule Technologie Sas | 2021 | 0 | — |
| +6 | K201770 | Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor | Masimo Corporation | 2020 | 1 | 2 |
| +6 | K191059 | Masimo Rad-97 and Accessories | Masimo Corporation | 2019 | 0 | — |
| +6 | K183697 | Masimo Rad-97 and Accessories | Masimo Corporation | 2019 | 9 | — |
| +7 | K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus… | Empatica S.r.l. | 2026 | 0 | — |
| +7 | K260157 | LifeLens Physiological Monitor | LifeLens Technologies, Inc. | 2026 | 0 | — |
| +7 | K252984 | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | 2026 | 0 | — |
| +7 | K252981 | EmbraceMini | Empatica S.r.l. | 2025 | 1 | — |
| +7 | K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2025 | 0 | — |
| +7 | K250757 | Radius VSM and Accessories | Masimo Corporation | 2025 | 0 | — |
| +7 | K241066 | BB-613-BPM | Biobeat Technologies, Ltd. | 2025 | 0 | — |
| +7 | K240236 | Happy Ring Health Monitoring System | Happy Health, Inc. | 2024 | 0 | — |
| +7 | K232915 | EpiMonitor | Empatica S.r.l. | 2024 | 1 | — |
| +7 | K231531 | Pediarity™ | Hinlab, Inc. | 2023 | 0 | — |
| +7 | K193626 | Masimo Rad-97 Pulse CO-Oximeter and Accessories | Masimo Corporation | 2020 | 1 | — |
| +8 | K250515 | EpiMonitor | Empatica S.r.l. | 2025 | 0 | — |