Devices descending from K003621
527 later devices reach ST/AR ST and Arrhythmia Software, Model Release D.0 through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +5 | K221348 | IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470) | Philips Medizin Systeme Böblingen GmbH | 2023 | 3 | — |
| +5 | K221704 | HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion… | Edwards Lifesciences, LLC | 2022 | 6 | — |
| +5 | K203638 | AT-Patch ECG Analysis System | Atsens Co., Ltd. | 2022 | 1 | — |
| +5 | K220111 | RespiraSense | Pmd Solutions | 2022 | 1 | — |
| +5 | K220530 | Tetragraph Neuromuscular Transmission Monitor | Senzime AB | 2022 | 1 | — |
| +5 | K210179 | QOCA Portable ECG Monitoring Device | Quanta Computer, Inc. | 2022 | 0 | — |
| +5 | K221616 | Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17 | Caf Medical Solutions, Inc. | 2022 | 0 | — |
| +5 | K212876 | Carescape SpO2 - Masimo | Masimo Corporation | 2021 | 2 | — |
| +5 | K210753 | KardiaMobile 6L | AliveCor, Inc. | 2021 | 2 | — |
| +5 | K203687 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction… | Edwards Lifesciences, LLC | 2021 | 18 | — |
| +5 | K203131 | EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2021 | 0 | — |
| +5 | K202456 | M5 Recorder | Global Instrumentation, LLC | 2020 | 0 | — |
| +5 | K201941 | Monitor B125, Monitor B105 | Ge Medical Systems Information Technologies, Inc. | 2020 | 3 | — |
| +5 | K192137 | IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 | Philips Medizin Systeme Boeblingen GmbH | 2020 | 0 | — |
| +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 | K190734 | Linshom Respiratory Monitoring Device (LRMD) | Linshom Management, LLC | 2020 | 2 | — |
| +5 | K182979 | IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2019 | 5 | — |
| +5 | K190205 | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | Edwards Lifesciences, LLC | 2019 | 34 | — |
| +5 | K191089 | Edwards Pressure Cable | Edwards Lifesciences, LLC | 2019 | 0 | — |
| +5 | K182637 | Philips IntelliVue XDS Software | Philips Medizin Systeme Boeblingen GmbH | 2019 | 0 | — |
| +5 | K173765 | Surveyor Patient Monitor | Mortara Instrument, Inc. | 2018 | 0 | 2 |
| +5 | K181314 | IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue… | Philips Medizin Systeme Boeblingen GmbH | 2018 | 6 | — |
| +5 | K173042 | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models… | Edan Instruments, Inc. | 2018 | 1 | 2 |
| +5 | K173461 | ECG recorder and Arrhythmia Detector | Smart Solutions Technologies SL | 2018 | 1 | — |
| +5 | K180017 | MX40 Release C.01 | Philips Medical Systems | 2018 | 1 | — |
| +5 | K172147 | STAR 65 | Skanray Technologies Pvt, Ltd. | 2018 | 0 | — |
| +5 | K171936 | Peerbridge Cor (TM) System | Peerbridge Health, Inc. | 2017 | 1 | — |
| +5 | K170876 | Passport Series Patient Monitors (Passport 12m, Passport 17m) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017 | 3 | — |
| +5 | K171322 | eCareManager 4.1 | Visicu, Inc. | 2017 | 2 | — |
| +5 | K170567 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2017 | 2 | — |
| +5 | K163512 | Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | 2017 | 18 | 1 |
| +5 | K163649 | SureSigns VS3; SureSigns VS4 | Philips Medical Systems | 2017 | 1 | 10 |
| +5 | K162503 | Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software | Cardiac Insight, Inc. | 2017 | 0 | — |
| +5 | K161056 | Telemetry Transmitter | Edan Instruments, Inc. | 2017 | 0 | 2 |
| +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 | K153335 | AlertWatch: OR | Alertwatch, LLC | 2016 | 1 | — |
| +5 | K151736 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boblingen GmbH | 2015 | 24 | — |
| +5 | K150030 | Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor | Fukuda Denshi USA, Inc. | 2015 | 0 | — |
| +5 | K142106 | Decisio Health Patient Dashboard | Decisio Health, Inc. | 2015 | 5 | — |
| +5 | K143195 | Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2014 | 9 | 1 |
| +5 | K140535 | Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50 | Philips Medizin Systeme Boblingen GmbH | 2014 | 0 | 5 |
| +5 | K142489 | Unimed Disposable ECG lead wires | Unimed Medical Supplies, Inc. | 2014 | 4 | — |
| +5 | K132447 | Vitalconnect Platform by Vital Connect Inc. | Vitalconnect, Inc. | 2014 | 1 | — |
| +5 | K132320 | Intellivue CL Respiration Pod | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2014 | 20 | — |
| +5 | K123711 | Patient Monitor | Shenzhen Creative Industry Co., Ltd. | 2013 | 13 | — |
| +5 | K131382 | Expression MR200 Mri Patient Monitoring System, Expression IP5 Information Portal | Invivo Corporation | 2013 | 0 | 5 |
| +5 | K130170 | Exspiron 1XI | Respiratory Motion, Inc. | 2013 | 4 | — |
| +5 | K124061 | Mri Patient Monitoring System (Model 865214) | Invivo Corporation | 2013 | 4 | 1 |
| +5 | K112877 | Comen Multi-Parameter Patient Monitor | Goldway (Us), Inc. | 2012 | 1 | — |
| +5 | K121914 | Masimo Set USPO2 Pulse Oximetry Cable | Masimo Corporation | 2012 | 0 | 1 |
| +5 | K121424 | Expression Information Portal | Invivo Corporation | 2012 | 2 | 4 |
| +5 | K102378 | Vectraplexecg System with Vectraplexami | Vectracor, Inc. | 2011 | 2 | — |
| +5 | K102958 | Philips Avalon Fetal Monitor | Philips Medizin Systeme Boblingen GmbH | 2011 | 2 | — |
| +5 | K103700 | Essential Mri Patient Monitor | Invivo Corporation | 2011 | 0 | — |
| +5 | K100420 | Philips Obtracevue Model SW Rev. G.00 | Philips Medizin Systeme Boeblingen GmbH | 2010 | 4 | — |
| +5 | K100394 | Multi-Parameter Patient Monitor, Model# PMS8210A | Shanghai 3f Electronics Co, Ltd. | 2010 | 1 | — |
| +5 | K092549 | Oxiprobe, Models BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P | Bio Medical Technologies Co., Ltd. | 2009 | 1 | — |
| +5 | K091572 | Disposable SPO2 Sensor M1134A | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009 | 38 | — |
| +5 | K091834 | Passport V Monitor, Model 0998-00-6100 | Datascope Corp., Patient Monitoring Division | 2009 | 0 | 2 |
| +5 | K082887 | PM-1000F+Patient Monitor | Advanced Instrumentations, Inc. | 2009 | 0 | — |
| +5 | K073280 | Beneview T Series Patient Monitors, Models T8, T6 and T5 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | 2 | — |
| +5 | K080173 | STAR 55 | Larsen & Toubro Limited | 2008 | 5 | — |
| +5 | K072581 | PM-60 Pulse Oximeter | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | 19 | — |
| +5 | K072346 | PM-7000 Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | 19 | — |
| +5 | K061329 | Infinity Masimo Set SP02 Pod | Draeger Medical Systems, Inc. | 2006 | 25 | — |
| +5 | K041815 | LNCS Oximetry Sensors | Masimo Corp. | 2004 | 86 | — |
| +6 | K253529 | Peerbridge COR MDx (Cor MDx) | Peerbridge Health, Inc. | 2026 | 0 | — |
| +6 | K251508 | Telemetry Monitor (iT30, iT50) | Edan Instruments, Inc. | 2026 | 0 | — |
| +6 | K261569 | UbiqVue™ 2AYe Cardiac System (UX2253) | Lifesignals, Inc. | 2026 | 0 | — |
| +6 | K261098 | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN… | Senzime AB | 2026 | 0 | — |
| +6 | K253654 | IntelliVue Measurement Rack 6000 (867317) | Philips Medizin Systeme Böblingen GmbH | 2026 | 0 | — |
| +6 | K253141 | DeepRhythmAI | Medicalgorithmics S.A. | 2025 | 0 | — |
| +6 | K252595 | Stethophone Pro | Sparrow Acoustics, Inc. | 2025 | 0 | — |
| +6 | K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | Edan Instruments, Inc. | 2025 | 0 | — |
| +6 | K250934 | Respiree Cardio- Respiratory Monitor System | Respiree Pte, Ltd. | 2025 | 0 | — |
| +6 | K242962 | Telemetry Monitor 5500 Release 4.0 (867232) | Philips Medizin Systeme Böblingen GmbH | 2025 | 0 | 1 |
| +6 | K242583 | AT-Patch (ATP-C130/ATP-C70) | Atsens Co., Ltd. | 2025 | 0 | — |
| +6 | K233953 | Makani Science™ Respiration Monitoring System | Makani Science, Inc. | 2025 | 0 | — |
| +6 | K231424 | HeartBeam AIMIGo (TM) System | Heartbeam, Inc. | 2024 | 0 | — |
| +6 | K240029 | Zio AT® device (A100A1001) | iRhythm Technologies, Inc. | 2024 | 1 | — |
| +6 | K240271 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. | 2024 | 1 | — |
| +6 | K233584 | RhythmStar System | RhythMedix, LLC | 2024 | 1 | — |
| +6 | K231671 | IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)… | Philips Medizin Systeme Boeblingen GmbH | 2023 | 2 | — |
| +6 | K230604 | IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) | Philips Medizin Systeme Boeblingen GmbH | 2023 | 1 | — |
| +6 | K232294 | HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart… | Edwards Lifesciences, LLC | 2023 | 5 | — |
| +6 | K231477 | Infinity CentralStation Wide, Infinity M300, Infinity M300+ | Draeger Medical Systems, Inc. | 2023 | 1 | — |
| +6 | K223574 | IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)… | Philips Medizin Systeme Boeblingen GmbH | 2023 | 2 | — |
| +6 | K231620 | Nuubo Smart | Smart Solutions Technologies SL | 2023 | 0 | — |
| +6 | K223567 | CNS-2101 Central Monitor | Nihon Kohden Corporation | 2023 | 2 | — |
| +6 | K231038 | Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences, LLC | 2023 | 6 | — |
| +6 | K230057 | Acumen Hypotension Prediction Index (HPI) Algorithm | Edwards Lifesciences, LLC | 2023 | 5 | — |
| +6 | K220117 | ARC Intensive Care Information System (ARC System) | Ordinatrum Solutions | 2023 | 0 | — |
| +6 | K220308 | Patient Monitor: RespArray | Edan Instruments, Inc. | 2022 | 1 | — |
| +6 | K221953 | Masimo CARESCAPE SpO2 – Masimo with SpHb | Masimo Corporation | 2022 | 1 | — |
| +6 | K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable… | Edwards Lifesciences, LLC | 2022 | 14 | — |
| +6 | K211046 | eCareManager 4.5 | Visicu, Inc. | 2022 | 0 | — |
| +6 | K220058 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022 | 3 | 1 |
| +6 | K220350 | KardiaMobile 6L | AliveCor, Inc. | 2022 | 0 | — |