Devices descending from K012891
548 later devices reach Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +7 | K253152 | BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) | Biozen, LLC | 2026 | 0 | — |
| +7 | K252726 | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100… | Philips Medizin Systeme Boeblingen GmbH | 2026 | 0 | — |
| +7 | K251146 | IntelliVue Patient monitors MX400, MX450, MX500, MX550 | Philips Medizin Systeme Boeblingen GmbH | 2025 | 0 | — |
| +7 | K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)… | Philips Medizin Systeme Böblingen GmbH | 2025 | 0 | — |
| +7 | K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | Edan Instruments, Inc. | 2025 | 0 | — |
| +7 | K250515 | EpiMonitor | Empatica S.r.l. | 2025 | 0 | — |
| +7 | K242962 | Telemetry Monitor 5500 Release 4.0 (867232) | Philips Medizin Systeme Böblingen GmbH | 2025 | 0 | 1 |
| +7 | K242352 | Accurate Mini Non-invasive blood pressure monitor (AMB-001) | Accurate Meditech, Inc. | 2025 | 0 | — |
| +7 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-… | Edwards Lifesciences | 2024 | 4 | — |
| +7 | K240320 | Patient Monitor (RespArray) | Edan Instruments, Inc. | 2024 | 0 | — |
| +7 | K232962 | Patient Monitor (iX10, iX12, iX15) | Edan Instruments, Inc. | 2024 | 2 | 1 |
| +7 | K231671 | IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)… | Philips Medizin Systeme Boeblingen GmbH | 2023 | 2 | — |
| +7 | K230612 | Edwards Algorithm for Measurement of Blood Hemoglobin | Edwards Lifesciences, LLC | 2023 | 5 | — |
| +7 | K231477 | Infinity CentralStation Wide, Infinity M300, Infinity M300+ | Draeger Medical Systems, Inc. | 2023 | 1 | — |
| +7 | K230415 | Cadwell Guardian | Cadwell Industries, Inc. | 2023 | 0 | — |
| +7 | K223567 | CNS-2101 Central Monitor | Nihon Kohden Corporation | 2023 | 2 | — |
| +7 | K220117 | ARC Intensive Care Information System (ARC System) | Ordinatrum Solutions | 2023 | 0 | — |
| +7 | K211619 | Multi-Parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | 2022 | 0 | — |
| +7 | K211046 | eCareManager 4.5 | Visicu, Inc. | 2022 | 0 | — |
| +7 | K220058 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022 | 3 | 1 |
| +7 | K213335 | Capsule Surveillance System | Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. | 2022 | 3 | — |
| +7 | K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2022 | 5 | — |
| +7 | K210160 | AlertWatch:AC | Alertwatch, Inc. | 2021 | 0 | — |
| +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 | K200717 | CLEWICU System (ClewICUServer and ClewICUnitor) | Clew Medical, Ltd. | 2021 | 12 | — |
| +7 | K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | Edwards Lifesiences, LLC | 2020 | 27 | 1 |
| +7 | K201432 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2020 | 2 | — |
| +7 | K190270 | FORE-SIGHT ELITE Tissue Oximeter Module | Cas Medical Systems, Inc. | 2019 | 15 | — |
| +7 | K183687 | LifeWindow LW8 Lite | Digicare Biomedical Technology, Inc. | 2019 | 1 | — |
| +7 | K181919 | Patient Monitor | Guangdong Biolight Meditech Co., Ltd. | 2019 | 0 | — |
| +7 | K190073 | Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case… | Current Health, Ltd. | 2019 | 18 | — |
| +7 | K183067 | Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2019 | 4 | — |
| +7 | K172965 | Handheld VitalSigns Monitoring System | Visiomed Technology Co.,Ltd | 2018 | 0 | — |
| +7 | K181196 | Caretaker Remote Display App and Caretaker Software Library | Caretaker Medical, LLC | 2018 | 1 | — |
| +7 | K181466 | Cadwell Zenith System | Cadwell Industries, Inc. | 2018 | 0 | — |
| +7 | K180534 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | 2018 | 2 | — |
| +7 | K172586 | Vios Monitoring System™ Model 2050 | Vios Medical, Inc. | 2018 | 2 | 4 |
| +7 | K180472 | ViSi Mobile Monitoring System | Sotera Wireless, Inc. | 2018 | 1 | — |
| +7 | K172011 | LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) | Hmicro, Inc. | 2018 | 1 | — |
| +7 | K173715 | AlertWatch:OB | Alertwatch, Inc. | 2018 | 0 | — |
| +7 | K171121 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2017 | 16 | — |
| +7 | K171580 | Monitor B125, Monitor B105 | Ge Medical Systems (China) Co., Ltd. | 2017 | 4 | 1 |
| +7 | K170538 | RVS-100 Vital Signs Monitor | Rudolf Riester GmbH | 2017 | 0 | — |
| +7 | K170168 | Masimo Rad-97 and Accessories | Masimo Corporation | 2017 | 14 | — |
| +7 | K163649 | SureSigns VS3; SureSigns VS4 | Philips Medical Systems | 2017 | 1 | 10 |
| +7 | K152902 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 6 | 1 |
| +7 | K142209 | Pulse oximeter NBM-200 | Orsense, Ltd. | 2015 | 0 | — |
| +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 | K131382 | Expression MR200 Mri Patient Monitoring System, Expression IP5 Information Portal | Invivo Corporation | 2013 | 0 | 5 |
| +7 | K124061 | Mri Patient Monitoring System (Model 865214) | Invivo Corporation | 2013 | 4 | 1 |
| +7 | K121424 | Expression Information Portal | Invivo Corporation | 2012 | 2 | 4 |
| +7 | K113798 | Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set | Draeger Medical Systems, Inc. | 2012 | 23 | 8 |
| +7 | K103700 | Essential Mri Patient Monitor | Invivo Corporation | 2011 | 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 | K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | 2025 | 0 | — |
| +8 | K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot… | Philips Medizin Systeme Böblingen GmbH | 2025 | 1 | — |
| +8 | K242728 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025 | 0 | 2 |
| +8 | K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | Edan Instruments, Inc. | 2025 | 0 | — |
| +8 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere… | Edwards Lifesciences | 2025 | 2 | 1 |
| +8 | K242750 | Central Station | Nihon Kohden Digital Health Solutions, LLC | 2025 | 1 | — |
| +8 | K241958 | WARD-CSS (v1.2.x) | Ward 24/7 Aps | 2025 | 0 | — |
| +8 | K241728 | Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server… | Murata Vios, Inc. | 2025 | 0 | — |
| +8 | K240312 | Infinity CentralStation Wide | Draeger Medical Systems, Inc. | 2024 | 0 | — |
| +8 | K240756 | Aitrics-VC | Aitrics Co., Ltd. | 2024 | 0 | — |
| +8 | K233354 | WVSM Pro (Series) (500-0030-XX) | Athena Gtx, Inc. | 2024 | 0 | — |
| +8 | K233253 | eCARTv5 Clinical Deterioration Suite (“eCART”) | Agilemd, Inc. | 2024 | 1 | — |
| +8 | K233133 | Talis EMR with Talis +ACG (Talis EMR with +ACG) | Talis Clinical, LLC | 2024 | 0 | — |
| +8 | K232354 | Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server… | Murata Vios, Inc. | 2024 | 0 | — |
| +8 | K232694 | Central Monitoring System (MFM-CMS) | Edan Instruments, Inc. | 2024 | 1 | 1 |
| +8 | K233216 | CLEWICU System | Clew Medical, Ltd. | 2024 | 0 | — |
| +8 | K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2023 | 1 | — |
| +8 | K230626 | Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services… | Ge Medical Systems Information Technologies, Inc. | 2023 | 2 | 1 |
| +8 | K231038 | Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences, LLC | 2023 | 6 | — |
| +8 | K221833 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module | Edwards Lifesciences, LLC | 2022 | 7 | — |
| +8 | K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2022 | 1 | — |
| +8 | K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable… | Edwards Lifesciences, LLC | 2022 | 14 | — |
| +8 | K203208 | Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2022 | 3 | — |
| +8 | K214072 | Masimo O3 Regional Oximeter System | 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 | K212219 | AHI System | Fifth Eye, Inc. | 2021 | 1 | — |
| +8 | K212227 | Philips MR Patient Care Portal | Invivo Corporation | 2021 | 0 | 1 |
| +8 | K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X) | Philips Medizin Systeme Boeblingen GmbH | 2021 | 0 | — |
| +8 | K211588 | Caretaker Platform, VitalStream Platform, CT5 | Caretaker Medical | 2021 | 0 | — |
| +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 | K202189 | Graffiti | Ge Medical Systems Information Technologies, Inc. | 2020 | 0 | — |
| +8 | K200856 | SmartLinx Vitals Plus Patient Monitoring System | Capsule Technologie Sas | 2020 | 1 | — |
| +8 | K192952 | Spire Health Remote Patient Monitoring System | Spire, Inc. D/B/A Spire Health | 2020 | 0 | — |
| +8 | K191882 | Masimo Centroid System | Masimo Corporation | 2020 | 3 | — |
| +8 | K193242 | Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and… | Masimo Corporation | 2020 | 7 | — |
| +8 | K191272 | Wearable Device, Wearable Package | Current Health, Ltd. | 2019 | 16 | — |
| +8 | K191331 | Life Sensor Cardiac Monitor | Braveheart Wireless, Inc. | 2019 | 0 | — |
| +8 | K180903 | 3880 MRI Patient Monitoring System | Iradimed Corporation | 2019 | 0 | — |
| +8 | K180046 | Masimo Rad-97 and Accessories | Masimo Corporation | 2018 | 13 | 1 |
| +8 | K171901 | uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017 | 0 | — |
| +8 | K160746 | CARDIOLINE touchECG | Cardioline S.P.A | 2016 | 0 | — |