Devices descending from K040011
320 later devices reach Polaris 2004 Capnograph through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +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 | K210906 | IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot… | Philips Medizin Systeme Boeblingen GmbH | 2021 | 6 | 2 |
| +7 | K212008 | Reveal LINQ Insertable Cardiac Monitor | Medtronic, Inc. | 2021 | 0 | — |
| +7 | K202375 | ZOLL Propaq M | ZOLL Medical Corporation | 2021 | 1 | — |
| +7 | K201635 | MouthLab Vital Signs Monitoring System | Multisensor Diagnostics (Dba Aidar Health) | 2021 | 0 | — |
| +7 | K201865 | Biomonitor III, Biomonitor IIIm | Biotronik, Inc. | 2020 | 3 | — |
| +7 | K201746 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies Limited | 2020 | 0 | 7 |
| +7 | K192137 | IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 | Philips Medizin Systeme Boeblingen GmbH | 2020 | 0 | — |
| +7 | K201179 | GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable | Covidien, LLC | 2020 | 0 | — |
| +7 | K182979 | IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2019 | 5 | — |
| +7 | K183687 | LifeWindow LW8 Lite | Digicare Biomedical Technology, Inc. | 2019 | 1 | — |
| +7 | K190090 | DynoSense Vital Sign Measuring System | Dynosense Corp. | 2019 | 0 | — |
| +7 | K182637 | Philips IntelliVue XDS Software | Philips Medizin Systeme Boeblingen GmbH | 2019 | 0 | — |
| +7 | K181352 | Loop System | Spry Health, Inc. | 2019 | 10 | — |
| +7 | K190073 | Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case… | Current Health, Ltd. | 2019 | 18 | — |
| +7 | K181831 | IntelliVue Multi-Measurement Module MMX | Philips Medizin Systeme Boeblingen GmbH | 2018 | 0 | — |
| +7 | K181314 | IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue… | Philips Medizin Systeme Boeblingen GmbH | 2018 | 6 | — |
| +7 | K180534 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | 2018 | 2 | — |
| +7 | K172147 | STAR 65 | Skanray Technologies Pvt, Ltd. | 2018 | 0 | — |
| +7 | K172890 | SedLine Sedation Monitor | Masimo Corporation | 2018 | 5 | — |
| +7 | K171801 | IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic… | Philips Medizin Systeme Boeblingen GmbH | 2017 | 8 | 4 |
| +7 | K170876 | Passport Series Patient Monitors (Passport 12m, Passport 17m) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017 | 3 | — |
| +7 | K163649 | SureSigns VS3; SureSigns VS4 | Philips Medical Systems | 2017 | 1 | 10 |
| +7 | K161909 | IQvitals Zone | Midmark Corporation | 2016 | 1 | 4 |
| +7 | K152659 | V10 | Mediana Co., Ltd. | 2016 | 2 | — |
| +7 | K142209 | Pulse oximeter NBM-200 | Orsense, Ltd. | 2015 | 0 | — |
| +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 | K123690 | CAPNOSTREAM20P with Hifi C02 Monitoring | Oridion Medical 1987, Ltd. | 2014 | 0 | Class I |
| +7 | K133988 | Tempus Pro Extended Features | Remote Diagnostic Technologies, Ltd. | 2014 | 3 | — |
| +7 | K113798 | Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set | Draeger Medical Systems, Inc. | 2012 | 23 | 8 |
| +7 | K112687 | Connex (R) Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | 66 | — |
| +8 | K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | Midmark Corporation | 2026 | 0 | — |
| +8 | 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 | — |
| +8 | K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | Edan Instruments, Inc. | 2025 | 0 | — |
| +8 | K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | Welch Allyn, Inc. | 2024 | 0 | 1 |
| +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 | K233354 | WVSM Pro (Series) (500-0030-XX) | Athena Gtx, Inc. | 2024 | 0 | — |
| +8 | K232445 | CSF-4 (CSF-4) | Cardiacsense | 2024 | 0 | — |
| +8 | K230604 | IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) | Philips Medizin Systeme Boeblingen GmbH | 2023 | 1 | — |
| +8 | K232294 | HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart… | Edwards Lifesciences, LLC | 2023 | 5 | — |
| +8 | K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2023 | 4 | — |
| +8 | K223574 | IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)… | Philips Medizin Systeme Boeblingen GmbH | 2023 | 2 | — |
| +8 | K221348 | IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470) | Philips Medizin Systeme Böblingen GmbH | 2023 | 3 | — |
| +8 | K222010 | Biobeat Platform-2 and BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | 1 | — |
| +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 | — |
| +8 | K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | 2022 | 7 | — |
| +8 | K220351 | Polso Watch | Chronisense Medical, Ltd. | 2022 | 0 | — |
| +8 | K220530 | Tetragraph Neuromuscular Transmission Monitor | Senzime AB | 2022 | 1 | — |
| +8 | K221856 | BIOMONITOR IIIm, BIOMONITOR III | Biotronik, Inc. | 2022 | 2 | — |
| +8 | K203113 | Masimo SedLine Sedation Monitor and Accessories | Masimo Corporation | 2022 | 1 | — |
| +8 | K203088 | Infinity Acute Care System (IACS) Monitoring System | Draeger Medical Systems, Inc. | 2022 | 1 | 1 |
| +8 | K201764 | Infinity Acute Care System (IACS) Monitoring Solution | Draeger Medical Systems, Inc. | 2021 | 2 | — |
| +8 | K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X) | Philips Medizin Systeme Boeblingen GmbH | 2021 | 0 | — |
| +8 | K202189 | Graffiti | Ge Medical Systems Information Technologies, Inc. | 2020 | 0 | — |
| +8 | K192952 | Spire Health Remote Patient Monitoring System | Spire, Inc. D/B/A Spire Health | 2020 | 0 | — |
| +8 | K191106 | C50 and C80 Multi-parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | 2019 | 1 | — |
| +8 | K191272 | Wearable Device, Wearable Package | Current Health, Ltd. | 2019 | 16 | — |
| +8 | K190011 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019 | 0 | 2 |
| +8 | K170497 | V10 | Mediana Co., Ltd. | 2017 | 1 | 1 |
| +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 | K260579 | Infinity® Acute Care System (IACS) – VG8.1 | Draeger Medical Systems, Inc. | 2026 | 0 | — |
| +9 | K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus… | Empatica S.r.l. | 2026 | 0 | — |
| +9 | K260880 | SedLine Sedation Monitor | Masimo Corporation | 2026 | 0 | — |
| +9 | K260157 | LifeLens Physiological Monitor | LifeLens Technologies, Inc. | 2026 | 0 | — |
| +9 | K261098 | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN… | Senzime AB | 2026 | 0 | — |
| +9 | K252726 | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100… | Philips Medizin Systeme Boeblingen GmbH | 2026 | 0 | — |
| +9 | K252984 | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | 2026 | 0 | — |
| +9 | K252981 | EmbraceMini | Empatica S.r.l. | 2025 | 1 | — |
| +9 | K251146 | IntelliVue Patient monitors MX400, MX450, MX500, MX550 | Philips Medizin Systeme Boeblingen GmbH | 2025 | 0 | — |
| +9 | K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)… | Philips Medizin Systeme Böblingen GmbH | 2025 | 0 | — |
| +9 | K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2025 | 0 | — |
| +9 | K241066 | BB-613-BPM | Biobeat Technologies, Ltd. | 2025 | 0 | — |
| +9 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-… | Edwards Lifesciences | 2024 | 4 | — |
| +9 | K241397 | Hinscope | Hinlab Sas | 2024 | 0 | — |
| +9 | K240236 | Happy Ring Health Monitoring System | Happy Health, Inc. | 2024 | 0 | — |
| +9 | K232915 | EpiMonitor | Empatica S.r.l. | 2024 | 1 | — |
| +9 | K231671 | IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)… | Philips Medizin Systeme Boeblingen GmbH | 2023 | 2 | — |
| +9 | K230375 | Biomonitor IV | Biotronik, Inc. | 2023 | 1 | — |
| +9 | K213863 | Everion+ System | Biofourmis Singapore Pte., Ltd. | 2023 | 1 | — |
| +9 | K211619 | Multi-Parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | 2022 | 0 | — |
| +9 | K222550 | Current Health System | Current Health, Ltd. | 2022 | 1 | — |
| +9 | K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | 2021 | 8 | — |
| +9 | K171121 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2017 | 16 | — |
| +9 | K170168 | Masimo Rad-97 and Accessories | Masimo Corporation | 2017 | 14 | — |
| +10 | K261074 | Biomonitor IV (471155) | Biotronik, Inc. | 2026 | 0 | — |
| +10 | K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | 2025 | 0 | — |
| +10 | K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot… | Philips Medizin Systeme Böblingen GmbH | 2025 | 1 | — |
| +10 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere… | Edwards Lifesciences | 2025 | 2 | 1 |
| +10 | K250515 | EpiMonitor | Empatica S.r.l. | 2025 | 0 | — |
| +10 | K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. | 2024 | 0 | — |
| +10 | K232548 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2024 | 1 | — |
| +10 | K231506 | Current Health System | Current Health, Ltd. | 2023 | 0 | — |
| +10 | K230626 | Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services… | Ge Medical Systems Information Technologies, Inc. | 2023 | 2 | 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 | — |