Devices descending from K991823
785 later devices reach N-395 Pulse Oximeter, Model N-395 through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +7 | K260157 | LifeLens Physiological Monitor | LifeLens Technologies, Inc. | 2026 | 0 | — |
| +7 | K261098 | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN… | Senzime AB | 2026 | 0 | — |
| +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 | K252981 | EmbraceMini | Empatica S.r.l. | 2025 | 1 | — |
| +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 | K250934 | Respiree Cardio- Respiratory Monitor System | Respiree Pte, Ltd. | 2025 | 0 | — |
| +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 | K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2025 | 0 | — |
| +7 | K242518 | Hypertension Prediction Index (HePI) Algorithm | Edwards Lifesciences, LLC | 2025 | 0 | — |
| +7 | K233953 | Makani Science™ Respiration Monitoring System | Makani Science, Inc. | 2025 | 0 | — |
| +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 | K240236 | Happy Ring Health Monitoring System | Happy Health, Inc. | 2024 | 0 | — |
| +7 | K240271 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. | 2024 | 1 | — |
| +7 | K240320 | Patient Monitor (RespArray) | Edan Instruments, Inc. | 2024 | 0 | — |
| +7 | K233253 | eCARTv5 Clinical Deterioration Suite (“eCART”) | Agilemd, Inc. | 2024 | 1 | — |
| +7 | K231116 | Multi-parameter detector | Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. | 2024 | 0 | — |
| +7 | K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. | 2024 | 0 | — |
| +7 | K232962 | Patient Monitor (iX10, iX12, iX15) | Edan Instruments, Inc. | 2024 | 2 | 1 |
| +7 | K232548 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2024 | 1 | — |
| +7 | K232915 | EpiMonitor | Empatica S.r.l. | 2024 | 1 | — |
| +7 | K233216 | CLEWICU System | Clew Medical, Ltd. | 2024 | 0 | — |
| +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 | K231506 | Current Health System | Current Health, Ltd. | 2023 | 0 | — |
| +7 | K230626 | Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services… | Ge Medical Systems Information Technologies, Inc. | 2023 | 2 | 1 |
| +7 | K223711 | ANNE One | Sibel Health, Inc. | 2023 | 4 | — |
| +7 | K223865 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid… | Edwards Lifesciences, LLC | 2023 | 7 | — |
| +7 | K220117 | ARC Intensive Care Information System (ARC System) | Ordinatrum Solutions | 2023 | 0 | — |
| +7 | K223651 | Cerebral Adaptive Index (CAI) Algorithm | Edwards Lifesciences, LLC | 2023 | 6 | — |
| +7 | K222330 | The Heart Seat | Casana Care, Inc. | 2023 | 0 | — |
| +7 | K213431 | Handheld Pulse Oximeter | Shenzhen Witleaf Medical Electronics Co., Ltd. | 2023 | 0 | — |
| +7 | K211619 | Multi-Parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | 2022 | 0 | — |
| +7 | K221530 | ANNE Pediatric | Sibel, Inc. | 2022 | 0 | — |
| +7 | K221833 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module | Edwards Lifesciences, LLC | 2022 | 7 | — |
| +7 | K212975 | MedWand | Medwand Solutions, Inc. | 2022 | 1 | — |
| +7 | K213230 | T3 Platform Software | Etiometry, Inc. | 2022 | 12 | — |
| +7 | K211046 | eCareManager 4.5 | Visicu, Inc. | 2022 | 0 | — |
| +7 | K212300 | Pulse Oximeter | Shenzhen Mericonn Technology Co., Ltd. | 2022 | 0 | — |
| +7 | K213335 | Capsule Surveillance System | Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. | 2022 | 3 | — |
| +7 | K212219 | AHI System | Fifth Eye, Inc. | 2021 | 1 | — |
| +7 | K210160 | AlertWatch:AC | Alertwatch, Inc. | 2021 | 0 | — |
| +7 | K203224 | Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform | Edwards Lifesciences, LLC | 2021 | 1 | — |
| +7 | K211465 | HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform | Edwards Lfesciences | 2021 | 15 | — |
| +7 | K202375 | ZOLL Propaq M | ZOLL Medical Corporation | 2021 | 1 | — |
| +7 | K201432 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2020 | 2 | — |
| +7 | K200856 | SmartLinx Vitals Plus Patient Monitoring System | Capsule Technologie Sas | 2020 | 1 | — |
| +7 | K193391 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020 | 10 | 2 |
| +7 | K191882 | Masimo Centroid System | Masimo Corporation | 2020 | 3 | — |
| +7 | K193242 | Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and… | Masimo Corporation | 2020 | 7 | — |
| +7 | K190624 | EarlyVue VS30 | Philips Medizin Systeme Boeblingen GmbH | 2019 | 0 | 3 |
| +7 | K190270 | FORE-SIGHT ELITE Tissue Oximeter Module | Cas Medical Systems, Inc. | 2019 | 15 | — |
| +7 | K190916 | VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 | Vitalconnect, Inc. | 2019 | 2 | — |
| +7 | K180903 | 3880 MRI Patient Monitoring System | Iradimed Corporation | 2019 | 0 | — |
| +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 | K182543 | Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device… | Snap40, Ltd. | 2018 | 19 | — |
| +7 | K180046 | Masimo Rad-97 and Accessories | Masimo Corporation | 2018 | 13 | 1 |
| +7 | K173976 | Masimo Acoustic Respiration Sensors, infant and neonate | Masimo Corporation | 2018 | 0 | — |
| +7 | K180017 | MX40 Release C.01 | Philips Medical Systems | 2018 | 1 | — |
| +7 | K180472 | ViSi Mobile Monitoring System | Sotera Wireless, Inc. | 2018 | 1 | — |
| +7 | K173715 | AlertWatch:OB | Alertwatch, Inc. | 2018 | 0 | — |
| +7 | K172141 | Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. | 2018 | 0 | — |
| +7 | K162131 | ExSpiron 1Xi | Respiratory Motion, Inc. | 2017 | 3 | — |
| +7 | K162199 | Cascade IOMAX Intraoperative Monitor | Cadwell Industries, Inc. | 2017 | 7 | 3 |
| +7 | K161767 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | 2017 | 23 | — |
| +7 | K153702 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2016 | 3 | 12 |
| +7 | K160951 | Philips Efficia CMS200 Central Monitoring System | Philips Medical Systems | 2016 | 0 | 1 |
| +7 | K153135 | Vital Signs Monitor | Guangdong Biolight Meditech Co., Ltd. | 2016 | 2 | — |
| +7 | K152902 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 6 | 1 |
| +7 | K151063 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2015 | 5 | 1 |
| +7 | K151761 | SureSigns VS3, SureSigns VS4 | Phillips Medical Systems | 2015 | 2 | — |
| +7 | K143676 | B40i Patient Monitor | GE Healthcare Finland Oy | 2015 | 4 | 1 |
| +7 | K150055 | OneStep Pediatric CPR Multi-Function Electrode | Bio-Detek, Inc. | 2015 | 0 | — |
| +7 | K124041 | NBM-200MP | Orsense, Ltd. | 2013 | 1 | — |
| +7 | K112368 | CAPNOSTREAM20P with AI/Odi | Oridion Medical 1987, Ltd. | 2012 | 6 | 6 |
| +7 | K112687 | Connex (R) Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | 66 | — |
| +7 | K103285 | Dixtal DZ-4100 Series Pulse Oximeter | Dixtal Medical, Inc. | 2011 | 0 | — |
| +7 | K110028 | Masimo Radical Y Pulse CO-Oximeter | Masimo Corporation | 2011 | 89 | — |
| +7 | K090785 | Mri Compatible Patient Monitoring System, Model 865214 | Invivo Corp. | 2009 | 9 | 6 |
| +8 | K263010 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | inomed Medizintechnik GmbH | 2026 | 0 | — |
| +8 | K260008 | Deterioration Index Version 2 | Epic Systems Corporation | 2026 | 0 | — |
| +8 | K253417 | Masimo Root Monitoring System | Masimo Corporation | 2026 | 0 | — |
| +8 | K251508 | Telemetry Monitor (iT30, iT50) | Edan Instruments, Inc. | 2026 | 0 | — |
| +8 | K261367 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 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 | K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026 | 0 | — |
| +8 | K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | 2025 | 0 | — |
| +8 | K253034 | HemoSphere Stream Module | Edwards Lifesciences | 2025 | 0 | — |
| +8 | K250093 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. | 2025 | 0 | — |
| +8 | K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | Edan Instruments, Inc. | 2025 | 0 | — |
| +8 | K250515 | EpiMonitor | Empatica S.r.l. | 2025 | 0 | — |
| +8 | K243837 | iBSM | Iorbit Digital Technologies Private Limited | 2025 | 0 | — |
| +8 | K242962 | Telemetry Monitor 5500 Release 4.0 (867232) | Philips Medizin Systeme Böblingen GmbH | 2025 | 0 | 1 |
| +8 | K241958 | WARD-CSS (v1.2.x) | Ward 24/7 Aps | 2025 | 0 | — |
| +8 | K242842 | ANNE View, Central Hub | Sibel Health, Inc. | 2025 | 1 | — |
| +8 | K240596 | Cerebral Autoregulation Index (CAI) Algorithm | Edwards Lifesciences | 2024 | 0 | — |