Devices descending from K040183
274 later devices reach BISX through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +4 | K203687 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction… | Edwards Lifesciences, LLC | 2021 | 18 | — |
| +4 | K203131 | EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2021 | 0 | — |
| +4 | K201941 | Monitor B125, Monitor B105 | Ge Medical Systems Information Technologies, Inc. | 2020 | 3 | — |
| +4 | K200434 | V20, V20a, AVSM3 SNF | Mediana Co., Ltd. | 2020 | 0 | 1 |
| +4 | K192137 | IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 | Philips Medizin Systeme Boeblingen GmbH | 2020 | 0 | — |
| +4 | K190734 | Linshom Respiratory Monitoring Device (LRMD) | Linshom Management, LLC | 2020 | 2 | — |
| +4 | K182979 | IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2019 | 5 | — |
| +4 | K190205 | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | Edwards Lifesciences, LLC | 2019 | 34 | — |
| +4 | K191089 | Edwards Pressure Cable | Edwards Lifesciences, LLC | 2019 | 0 | — |
| +4 | K182637 | Philips IntelliVue XDS Software | Philips Medizin Systeme Boeblingen GmbH | 2019 | 0 | — |
| +4 | K173765 | Surveyor Patient Monitor | Mortara Instrument, Inc. | 2018 | 0 | 2 |
| +4 | K173042 | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models… | Edan Instruments, Inc. | 2018 | 1 | 2 |
| +4 | K172147 | STAR 65 | Skanray Technologies Pvt, Ltd. | 2018 | 0 | — |
| +4 | K172226 | MX40 Release B.07 | Philips Medical Systems | 2017 | 13 | — |
| +4 | K171801 | IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic… | Philips Medizin Systeme Boeblingen GmbH | 2017 | 8 | 4 |
| +4 | K170876 | Passport Series Patient Monitors (Passport 12m, Passport 17m) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017 | 3 | — |
| +4 | K171322 | eCareManager 4.1 | Visicu, Inc. | 2017 | 2 | — |
| +4 | K170567 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2017 | 2 | — |
| +4 | K160981 | Patient Monitor | Edan Instruments, Inc. | 2016 | 8 | 1 |
| +4 | K152305 | Nihon Kohden Afib Detection Program QP-039P | Nihon Kohden Corporation | 2016 | 0 | — |
| +4 | K153335 | AlertWatch: OR | Alertwatch, LLC | 2016 | 1 | — |
| +4 | K153448 | Passport Series Patient Monitors (Including Passport 8, Passport 12) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 0 | 2 |
| +4 | K151736 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boblingen GmbH | 2015 | 24 | — |
| +4 | K142106 | Decisio Health Patient Dashboard | Decisio Health, Inc. | 2015 | 5 | — |
| +4 | K143195 | Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2014 | 9 | 1 |
| +4 | K143057 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2014 | 4 | 1 |
| +4 | K140535 | Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50 | Philips Medizin Systeme Boblingen GmbH | 2014 | 0 | 5 |
| +4 | K132077 | Patient Monitor | Advanced Instrumentations, Inc. | 2014 | 0 | — |
| +4 | K132447 | Vitalconnect Platform by Vital Connect Inc. | Vitalconnect, Inc. | 2014 | 1 | — |
| +4 | K132320 | Intellivue CL Respiration Pod | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2014 | 20 | — |
| +4 | K131971 | IM60/IM70 Patient Monitor | Edan Instruments, Inc. | 2014 | 14 | 2 |
| +4 | K131032 | Philips Suresigns Central | Philips Medical Systems | 2013 | 1 | — |
| +4 | K130170 | Exspiron 1XI | Respiratory Motion, Inc. | 2013 | 4 | — |
| +4 | K123472 | Cimva Universal | Therapeutic Monitoring Systems (Tms), Inc. | 2013 | 0 | — |
| +4 | K123048 | Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A Pro | Advanced Instrumentations, Inc. | 2013 | 0 | — |
| +4 | K113125 | Intellivue MX40 Patient Monitor | Philips Medical Systems | 2011 | 14 | 16 |
| +4 | K102958 | Philips Avalon Fetal Monitor | Philips Medizin Systeme Boblingen GmbH | 2011 | 2 | — |
| +4 | K101521 | ST/AR ST and Arrhythmia Software Model: Release K.O | Philips Medical Systems | 2010 | 4 | — |
| +4 | K100420 | Philips Obtracevue Model SW Rev. G.00 | Philips Medizin Systeme Boeblingen GmbH | 2010 | 4 | — |
| +4 | K083228 | Philips Intellivue MP5 Patient Monitor | Philips Medizin Systeme Boblingen GmbH | 2008 | 85 | — |
| +4 | K081937 | Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry… | Philips Medizin Systeme Boeblingen GmbH | 2008 | 49 | — |
| +5 | K261098 | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN… | Senzime AB | 2026 | 0 | — |
| +5 | K253654 | IntelliVue Measurement Rack 6000 (867317) | Philips Medizin Systeme Böblingen GmbH | 2026 | 0 | — |
| +5 | K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | Edan Instruments, Inc. | 2025 | 0 | — |
| +5 | K250934 | Respiree Cardio- Respiratory Monitor System | Respiree Pte, Ltd. | 2025 | 0 | — |
| +5 | K233953 | Makani Science™ Respiration Monitoring System | Makani Science, Inc. | 2025 | 0 | — |
| +5 | K240271 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. | 2024 | 1 | — |
| +5 | K231671 | IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)… | Philips Medizin Systeme Boeblingen GmbH | 2023 | 2 | — |
| +5 | K230604 | IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) | Philips Medizin Systeme Boeblingen GmbH | 2023 | 1 | — |
| +5 | K232294 | HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart… | Edwards Lifesciences, LLC | 2023 | 5 | — |
| +5 | K223574 | IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)… | Philips Medizin Systeme Boeblingen GmbH | 2023 | 2 | — |
| +5 | K231038 | Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences, LLC | 2023 | 6 | — |
| +5 | K230057 | Acumen Hypotension Prediction Index (HPI) Algorithm | Edwards Lifesciences, LLC | 2023 | 5 | — |
| +5 | K220117 | ARC Intensive Care Information System (ARC System) | Ordinatrum Solutions | 2023 | 0 | — |
| +5 | K221616 | Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17 | Caf Medical Solutions, Inc. | 2022 | 0 | — |
| +5 | K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable… | Edwards Lifesciences, LLC | 2022 | 14 | — |
| +5 | K211046 | eCareManager 4.5 | Visicu, Inc. | 2022 | 0 | — |
| +5 | K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2022 | 2 | 6 |
| +5 | K213335 | Capsule Surveillance System | Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. | 2022 | 3 | — |
| +5 | K210160 | AlertWatch:AC | Alertwatch, Inc. | 2021 | 0 | — |
| +5 | K200717 | CLEWICU System (ClewICUServer and ClewICUnitor) | Clew Medical, Ltd. | 2021 | 12 | — |
| +5 | K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | Edwards Lifesiences, LLC | 2020 | 27 | 1 |
| +5 | K193391 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020 | 10 | 2 |
| +5 | K192514 | Patient Monitor | Edan Instruments, Inc. | 2020 | 6 | 1 |
| +5 | K191870 | VV330 Continuous ECG Platform, VivaLNK Adhesive Patch | VivaLNK, Inc. | 2020 | 0 | — |
| +5 | K191106 | C50 and C80 Multi-parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | 2019 | 1 | — |
| +5 | K190011 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019 | 0 | 2 |
| +5 | K182543 | Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device… | Snap40, Ltd. | 2018 | 19 | — |
| +5 | K173941 | IntelliSpace Perinatal Rev.K.00 | Philips Medizin Systeme Boeblingen GmbH | 2018 | 1 | — |
| +5 | K180017 | MX40 Release C.01 | Philips Medical Systems | 2018 | 1 | — |
| +5 | K173715 | AlertWatch:OB | Alertwatch, Inc. | 2018 | 0 | — |
| +5 | K173768 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2018 | 1 | — |
| +5 | K162131 | ExSpiron 1Xi | Respiratory Motion, Inc. | 2017 | 3 | — |
| +5 | K161056 | Telemetry Transmitter | Edan Instruments, Inc. | 2017 | 0 | 2 |
| +5 | K161767 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | 2017 | 23 | — |
| +5 | K153702 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2016 | 3 | 12 |
| +5 | K160951 | Philips Efficia CMS200 Central Monitoring System | Philips Medical Systems | 2016 | 0 | 1 |
| +5 | K152902 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 6 | 1 |
| +5 | K150082 | Panorama Patient Monitoring Network | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 0 | 1 |
| +5 | K150352 | V Series Monitoring System (including V12 and V21 Monitors) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 1 | — |
| +5 | K103285 | Dixtal DZ-4100 Series Pulse Oximeter | Dixtal Medical, Inc. | 2011 | 0 | — |
| +5 | K090785 | Mri Compatible Patient Monitoring System, Model 865214 | Invivo Corp. | 2009 | 9 | 6 |
| +6 | K251508 | Telemetry Monitor (iT30, iT50) | Edan Instruments, Inc. | 2026 | 0 | — |
| +6 | K252726 | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100… | Philips Medizin Systeme Boeblingen GmbH | 2026 | 0 | — |
| +6 | K250093 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. | 2025 | 0 | — |
| +6 | K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)… | Philips Medizin Systeme Böblingen GmbH | 2025 | 0 | — |
| +6 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere… | Edwards Lifesciences | 2025 | 2 | 1 |
| +6 | K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2025 | 0 | — |
| +6 | K242518 | Hypertension Prediction Index (HePI) Algorithm | Edwards Lifesciences, LLC | 2025 | 0 | — |
| +6 | K242962 | Telemetry Monitor 5500 Release 4.0 (867232) | Philips Medizin Systeme Böblingen GmbH | 2025 | 0 | 1 |
| +6 | K241958 | WARD-CSS (v1.2.x) | Ward 24/7 Aps | 2025 | 0 | — |
| +6 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-… | Edwards Lifesciences | 2024 | 4 | — |
| +6 | K240756 | Aitrics-VC | Aitrics Co., Ltd. | 2024 | 0 | — |
| +6 | K233253 | eCARTv5 Clinical Deterioration Suite (“eCART”) | Agilemd, Inc. | 2024 | 1 | — |
| +6 | K233810 | Portrait VSM | Ge Medical Systems Information Technologies, Inc. | 2024 | 0 | 1 |
| +6 | K233133 | Talis EMR with Talis +ACG (Talis EMR with +ACG) | Talis Clinical, LLC | 2024 | 0 | — |
| +6 | K233216 | CLEWICU System | Clew Medical, Ltd. | 2024 | 0 | — |
| +6 | K231477 | Infinity CentralStation Wide, Infinity M300, Infinity M300+ | Draeger Medical Systems, Inc. | 2023 | 1 | — |
| +6 | K223567 | CNS-2101 Central Monitor | Nihon Kohden Corporation | 2023 | 2 | — |
| +6 | K223865 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid… | Edwards Lifesciences, LLC | 2023 | 7 | — |