Devices descending from K923043
307 later devices reach Spectral Eeg Monitor Model A1000 through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +9 | K150352 | V Series Monitoring System (including V12 and V21 Monitors) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 1 | — |
| +9 | K103285 | Dixtal DZ-4100 Series Pulse Oximeter | Dixtal Medical, Inc. | 2011 | 0 | — |
| +9 | K090785 | Mri Compatible Patient Monitoring System, Model 865214 | Invivo Corp. | 2009 | 9 | 6 |
| +10 | K251508 | Telemetry Monitor (iT30, iT50) | Edan Instruments, Inc. | 2026 | 0 | — |
| +10 | K252726 | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100… | Philips Medizin Systeme Boeblingen GmbH | 2026 | 0 | — |
| +10 | K250093 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. | 2025 | 0 | — |
| +10 | K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)… | Philips Medizin Systeme Böblingen GmbH | 2025 | 0 | — |
| +10 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere… | Edwards Lifesciences | 2025 | 2 | 1 |
| +10 | K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2025 | 0 | — |
| +10 | K242518 | Hypertension Prediction Index (HePI) Algorithm | Edwards Lifesciences, LLC | 2025 | 0 | — |
| +10 | K242962 | Telemetry Monitor 5500 Release 4.0 (867232) | Philips Medizin Systeme Böblingen GmbH | 2025 | 0 | 1 |
| +10 | K241958 | WARD-CSS (v1.2.x) | Ward 24/7 Aps | 2025 | 0 | — |
| +10 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-… | Edwards Lifesciences | 2024 | 4 | — |
| +10 | K240756 | Aitrics-VC | Aitrics Co., Ltd. | 2024 | 0 | — |
| +10 | K233253 | eCARTv5 Clinical Deterioration Suite (“eCART”) | Agilemd, Inc. | 2024 | 1 | — |
| +10 | K233810 | Portrait VSM | Ge Medical Systems Information Technologies, Inc. | 2024 | 0 | 1 |
| +10 | K233133 | Talis EMR with Talis +ACG (Talis EMR with +ACG) | Talis Clinical, LLC | 2024 | 0 | — |
| +10 | K233216 | CLEWICU System | Clew Medical, Ltd. | 2024 | 0 | — |
| +10 | K231477 | Infinity CentralStation Wide, Infinity M300, Infinity M300+ | Draeger Medical Systems, Inc. | 2023 | 1 | — |
| +10 | K223567 | CNS-2101 Central Monitor | Nihon Kohden Corporation | 2023 | 2 | — |
| +10 | K223578 | T3 Platform software | Etiometry, Inc. | 2023 | 2 | — |
| +10 | K223865 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid… | Edwards Lifesciences, LLC | 2023 | 7 | — |
| +10 | K223651 | Cerebral Adaptive Index (CAI) Algorithm | Edwards Lifesciences, LLC | 2023 | 6 | — |
| +10 | K213423 | T3 Platform software | Etiometry, Inc. | 2023 | 2 | — |
| +10 | K211619 | Multi-Parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | 2022 | 0 | — |
| +10 | K222463 | EchoGo Heart Failure | Ultromics Limited | 2022 | 7 | — |
| +10 | K221833 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module | Edwards Lifesciences, LLC | 2022 | 7 | — |
| +10 | K223127 | HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable | Edwards Lifeciences, LLC | 2022 | 6 | — |
| +10 | K220308 | Patient Monitor: RespArray | Edan Instruments, Inc. | 2022 | 1 | — |
| +10 | K220732 | Mural Perinatal Surveillance | Ge Medical Systems Information Technologies, Inc. | 2022 | 0 | — |
| +10 | K220058 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022 | 3 | 1 |
| +10 | K212219 | AHI System | Fifth Eye, Inc. | 2021 | 1 | — |
| +10 | K203224 | Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform | Edwards Lifesciences, LLC | 2021 | 1 | — |
| +10 | K211465 | HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform | Edwards Lfesciences | 2021 | 15 | — |
| +10 | K203490 | FORE-SIGHT ELITE Absolute Tissue Oximeter | Edwards Lifesciences, LLC | 2021 | 0 | 1 |
| +10 | K202336 | Patient Monitor | Edan Instruments, Inc. | 2021 | 3 | 1 |
| +10 | K201746 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies Limited | 2020 | 0 | 7 |
| +10 | K190073 | Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case… | Current Health, Ltd. | 2019 | 18 | — |
| +10 | K180534 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | 2018 | 2 | — |
| +10 | K173181 | ExSpiron 1Xi | Respiratory Motion, Inc. | 2018 | 2 | — |
| +10 | K171901 | uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017 | 0 | — |
| +10 | K163584 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2017 | 2 | — |
| +10 | K160746 | CARDIOLINE touchECG | Cardioline S.P.A | 2016 | 0 | — |
| +10 | K131382 | Expression MR200 Mri Patient Monitoring System, Expression IP5 Information Portal | Invivo Corporation | 2013 | 0 | 5 |
| +10 | K124061 | Mri Patient Monitoring System (Model 865214) | Invivo Corporation | 2013 | 4 | 1 |
| +10 | K121424 | Expression Information Portal | Invivo Corporation | 2012 | 2 | 4 |
| +10 | K103700 | Essential Mri Patient Monitor | Invivo Corporation | 2011 | 0 | — |
| +11 | K260008 | Deterioration Index Version 2 | Epic Systems Corporation | 2026 | 0 | — |
| +11 | K260226 | ElintMAX Respiratory Monitor (ElintMAX Monitor A1) | Amptron Medical, Inc. | 2026 | 0 | — |
| +11 | K251326 | Respiration Rate algorithm | Edwards Lifesciences, LLC | 2026 | 0 | — |
| +11 | K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026 | 0 | — |
| +11 | K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | 2025 | 0 | — |
| +11 | K251293 | CardioVision | Icardio.Ai | 2025 | 0 | — |
| +11 | K253034 | HemoSphere Stream Module | Edwards Lifesciences | 2025 | 0 | — |
| +11 | K242728 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025 | 0 | 2 |
| +11 | K242750 | Central Station | Nihon Kohden Digital Health Solutions, LLC | 2025 | 1 | — |
| +11 | K241479 | Etiometry Platform (DAV 5.4 RAE 9.2) | Etiometry, Inc. | 2025 | 1 | — |
| +11 | K240860 | EchoGo Amyloidosis (1.0) | Ultromics Limited | 2024 | 2 | — |
| +11 | K240596 | Cerebral Autoregulation Index (CAI) Algorithm | Edwards Lifesciences | 2024 | 0 | — |
| +11 | K240013 | EchoGo Heart Failure (2.0) | Ultromics Limited | 2024 | 0 | — |
| +11 | K233984 | Acumen Assisted Fluid Management (AFM) Software Feature | Edwards Lifesciences, LLC | 2024 | 0 | — |
| +11 | K240312 | Infinity CentralStation Wide | Draeger Medical Systems, Inc. | 2024 | 0 | — |
| +11 | K240320 | Patient Monitor (RespArray) | Edan Instruments, Inc. | 2024 | 0 | — |
| +11 | K232962 | Patient Monitor (iX10, iX12, iX15) | Edan Instruments, Inc. | 2024 | 2 | 1 |
| +11 | K232694 | Central Monitoring System (MFM-CMS) | Edan Instruments, Inc. | 2024 | 1 | 1 |
| +11 | K230612 | Edwards Algorithm for Measurement of Blood Hemoglobin | Edwards Lifesciences, LLC | 2023 | 5 | — |
| +11 | K230842 | SignalHF (IM008) | Implicity, Inc. | 2023 | 0 | — |
| +11 | K223905 | Vivio® LVEDP System | Avicena, LLC | 2023 | 0 | — |
| +11 | K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced… | Edwards Lifesciencess, LLC | 2023 | 6 | 2 |
| +11 | K231335 | Cleerly ISCHEMIA | Cleerly, Inc. | 2023 | 0 | — |
| +11 | K221203 | AHI System | Fifth Eye, Inc. | 2022 | 0 | — |
| +11 | K212227 | Philips MR Patient Care Portal | Invivo Corporation | 2021 | 0 | 1 |
| +11 | K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X) | Philips Medizin Systeme Boeblingen GmbH | 2021 | 0 | — |
| +11 | K202189 | Graffiti | Ge Medical Systems Information Technologies, Inc. | 2020 | 0 | — |
| +11 | K192952 | Spire Health Remote Patient Monitoring System | Spire, Inc. D/B/A Spire Health | 2020 | 0 | — |
| +11 | K192595 | ExSpiron 2Xi | Respiratory Motion | 2019 | 0 | — |
| +11 | K183387 | M3290B Patient Information Center iX | Philips Medical Systems | 2019 | 0 | — |
| +11 | K191272 | Wearable Device, Wearable Package | Current Health, Ltd. | 2019 | 16 | — |
| +11 | K173203 | Athena GTX Device Management Suite (ADMS) Software | Athena Gtx | 2018 | 0 | — |
| +11 | K152330 | Expression MR400 MRI Patient Monitoring System | Invivo Corporation | 2015 | 2 | 1 |
| +11 | K132359 | Mri Patient Monitoring System | Invivo Corporation | 2013 | 0 | — |
| +12 | K260211 | Dashboard (P007000) | Hill-Rom, Inc. | 2026 | 0 | — |
| +12 | K250349 | Vista CMS | Shanghai Draeger Medical Instrument Co., Ltd. | 2026 | 0 | — |
| +12 | 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 | — |
| +12 | K254066 | Etiometry Platform | Etiometry, Inc. | 2026 | 0 | — |
| +12 | K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | Edan Instruments, Inc. | 2025 | 0 | — |
| +12 | K250151 | Us2.ca | Eko.Ai Pte Ltd. D/B/A Us2.Ai | 2025 | 0 | — |
| +12 | K243866 | InVision Precision Cardiac Amyloid | InVision Medical Technology Corporation | 2025 | 0 | — |
| +12 | K242909 | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | Edwards Lifesciences, LLC | 2025 | 0 | — |
| +12 | K241397 | Hinscope | Hinlab Sas | 2024 | 0 | — |
| +12 | K213863 | Everion+ System | Biofourmis Singapore Pte., Ltd. | 2023 | 1 | — |
| +12 | K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | 2022 | 7 | — |
| +12 | K222550 | Current Health System | Current Health, Ltd. | 2022 | 1 | — |
| +12 | K212271 | smart-sync | Northh Medical GmbH | 2022 | 0 | — |
| +12 | K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | 2021 | 8 | — |
| +12 | K182900 | 3880 MRI Patient Monitoring System | Iradimed Corporation | 2018 | 0 | — |
| +13 | K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. | 2024 | 0 | — |
| +13 | K232548 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2024 | 1 | — |
| +13 | K232915 | EpiMonitor | Empatica S.r.l. | 2024 | 1 | — |
| +13 | K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2023 | 4 | — |