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 |
|---|---|---|---|---|---|---|
| +6 | K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2022 | 2 | 6 |
| +6 | K213335 | Capsule Surveillance System | Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. | 2022 | 3 | — |
| +6 | K212227 | Philips MR Patient Care Portal | Invivo Corporation | 2021 | 0 | 1 |
| +6 | K210160 | AlertWatch:AC | Alertwatch, Inc. | 2021 | 0 | — |
| +6 | K203635 | Patient Monitoring Cables | Jkh USA, LLC | 2021 | 2 | — |
| +6 | K202336 | Patient Monitor | Edan Instruments, Inc. | 2021 | 3 | 1 |
| +6 | K200717 | CLEWICU System (ClewICUServer and ClewICUnitor) | Clew Medical, Ltd. | 2021 | 12 | — |
| +6 | K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | Edwards Lifesiences, LLC | 2020 | 27 | 1 |
| +6 | K191870 | VV330 Continuous ECG Platform, VivaLNK Adhesive Patch | VivaLNK, Inc. | 2020 | 0 | — |
| +6 | K192343 | Patient Monitor | Shenzhen Creative Industry Co., Ltd. | 2019 | 0 | — |
| +6 | K191106 | C50 and C80 Multi-parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | 2019 | 1 | — |
| +6 | K190011 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019 | 0 | 2 |
| +6 | K173036 | North-vision Multi-parameter Patient Monitor | North-Vision Tech., Inc. | 2018 | 0 | — |
| +6 | K182543 | Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device… | Snap40, Ltd. | 2018 | 19 | — |
| +6 | K172792 | Handheld Pulse Oximeter, Model SP-20 | Shenzhen Creative Industry Co., Ltd. | 2018 | 3 | — |
| +6 | K173941 | IntelliSpace Perinatal Rev.K.00 | Philips Medizin Systeme Boeblingen GmbH | 2018 | 1 | — |
| +6 | K181502 | Zio AT ECG Monitoring System, ZEUS System | iRhythm Technologies, Inc. | 2018 | 12 | — |
| +6 | K173952 | Universal SmartECG | Vectracor, Inc. | 2018 | 1 | — |
| +6 | K173454 | Multi-parameter Patient Monitor, models C30 | Shenzhen Comen Medical Instruments Co.,Ltd | 2018 | 0 | — |
| +6 | K173715 | AlertWatch:OB | Alertwatch, Inc. | 2018 | 0 | — |
| +6 | K173768 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2018 | 1 | — |
| +6 | K170047 | All-in-One Health Monitor, PC-303 | Shenzhen Creative Industry Co., Ltd. | 2017 | 6 | — |
| +6 | K163584 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2017 | 2 | — |
| +6 | K162131 | ExSpiron 1Xi | Respiratory Motion, Inc. | 2017 | 3 | — |
| +6 | K161767 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | 2017 | 23 | — |
| +6 | K153188 | Caremed patient cable and leadwires | Shenzhen Caremed Medical Technology Co., Ltd. | 2016 | 0 | — |
| +6 | K152902 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 6 | 1 |
| +6 | K152330 | Expression MR400 MRI Patient Monitoring System | Invivo Corporation | 2015 | 2 | 1 |
| +6 | K132516 | Oxiprobe E (Oxiprobe) | Bio Medical Technologies Co., Ltd. | 2014 | 0 | — |
| +6 | K132359 | Mri Patient Monitoring System | Invivo Corporation | 2013 | 0 | — |
| +6 | K113798 | Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set | Draeger Medical Systems, Inc. | 2012 | 23 | 8 |
| +6 | K113183 | PMS8210A (Iris) Multi-Parameter Patient Monitor, Model Code 500 | Shanghai 3f Electronics Co, Ltd. | 2012 | 0 | — |
| +6 | K110922 | Patient Monitor | Edan Instruments, Inc. | 2011 | 1 | 1 |
| +6 | K101692 | Patient Monitor | Contec Medical System Co., Ltd. | 2011 | 0 | 1 |
| +6 | K103686 | STAR 50 N | Larsen & Toubro Limited | 2011 | 1 | — |
| +6 | K102560 | Reprocessed Pulse Oximeter Sensors | Sterilmed, Inc. | 2011 | 0 | — |
| +6 | K101280 | Midwestern Reprocessing Center Reprocessed Pulse Oximeter Probe | Midwest Reprocessing Center, LLC | 2010 | 0 | — |
| +6 | K100046 | M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000 | Guangdong Biolight Meditech Co., Ltd. | 2010 | 16 | — |
| +6 | K092970 | General Patient Monitors, Models: G3C/ G3D/ G3F/ G3G/ G3H | General Meditech, Inc. | 2010 | 0 | — |
| +6 | K092727 | H100B Pulse Oximeter | Edan Instruments, Inc. | 2009 | 0 | — |
| +6 | K092368 | Reprocessed Pulse Oximeter Sensors | Sterilmed, Inc. | 2009 | 0 | — |
| +6 | K083719 | LNCS Oximetry Sensors | Masimo Corporation | 2009 | 2 | — |
| +6 | K090599 | MD300K1 Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | 2009 | 9 | — |
| +6 | K090671 | Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60D | Contec Medical System Co., Ltd. | 2009 | 3 | — |
| +6 | K090172 | Star 55 Model 100 | Larsen & Toubro Limited | 2009 | 0 | — |
| +6 | K083622 | LNCS Oximetry Sensors | Masimo Corporation | 2009 | 1 | — |
| +6 | K082888 | Infinity Nellcor Oximax Smartpod, Model MS23997 | Draeger Medical Systems, Inc. | 2008 | 0 | — |
| +6 | K082685 | Galaxy 55 | Larsen & Toubro Limited | 2008 | 0 | — |
| +6 | K081712 | Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700 | Guangdong Biolight Meditech Co., Ltd. | 2008 | 3 | — |
| +6 | K081238 | Reprocessed Masimo Pulse Oximeter Sensors | Ascent Healthcare Solutions | 2008 | 3 | — |
| +6 | K080424 | Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and… | Hygia Health Services, Inc. | 2008 | 1 | — |
| +6 | K060143 | LNCS and SPO2.Com Sensors | Masimo Corporation | 2006 | 10 | — |
| +6 | K051212 | Modification to LNCS Oximetry Sensors | Masimo Corporation | 2005 | 85 | 5 |
| +7 | K253436 | c-med0 alpha | Cosinuss GmbH | 2026 | 0 | — |
| +7 | K250793 | RhythmStar System (SL) | RhythMedix, LLC | 2026 | 0 | — |
| +7 | K252726 | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100… | Philips Medizin Systeme Boeblingen GmbH | 2026 | 0 | — |
| +7 | K250093 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. | 2025 | 0 | — |
| +7 | K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)… | Philips Medizin Systeme Böblingen GmbH | 2025 | 0 | — |
| +7 | K242728 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025 | 0 | 2 |
| +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 | K242750 | Central Station | Nihon Kohden Digital Health Solutions, LLC | 2025 | 1 | — |
| +7 | K242518 | Hypertension Prediction Index (HePI) Algorithm | Edwards Lifesciences, LLC | 2025 | 0 | — |
| +7 | K241958 | WARD-CSS (v1.2.x) | Ward 24/7 Aps | 2025 | 0 | — |
| +7 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-… | Edwards Lifesciences | 2024 | 4 | — |
| +7 | K240177 | Zio AT® device (A100A1001) | iRhythm Technologies, Inc. | 2024 | 0 | — |
| +7 | K240312 | Infinity CentralStation Wide | Draeger Medical Systems, Inc. | 2024 | 0 | — |
| +7 | K240756 | Aitrics-VC | Aitrics Co., Ltd. | 2024 | 0 | — |
| +7 | K240320 | Patient Monitor (RespArray) | Edan Instruments, Inc. | 2024 | 0 | — |
| +7 | K233253 | eCARTv5 Clinical Deterioration Suite (“eCART”) | Agilemd, Inc. | 2024 | 1 | — |
| +7 | K232035 | Impala | AliveCor, Inc. | 2024 | 0 | — |
| +7 | K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV… | Physio-Control, Inc. | 2024 | 0 | — |
| +7 | K233810 | Portrait VSM | Ge Medical Systems Information Technologies, Inc. | 2024 | 0 | 1 |
| +7 | K232962 | Patient Monitor (iX10, iX12, iX15) | Edan Instruments, Inc. | 2024 | 2 | 1 |
| +7 | K233133 | Talis EMR with Talis +ACG (Talis EMR with +ACG) | Talis Clinical, LLC | 2024 | 0 | — |
| +7 | K232694 | Central Monitoring System (MFM-CMS) | Edan Instruments, Inc. | 2024 | 1 | 1 |
| +7 | K231625 | VitalDetect | Wellvii, Inc. | 2024 | 0 | — |
| +7 | K233216 | CLEWICU System | Clew Medical, Ltd. | 2024 | 0 | — |
| +7 | K222712 | Fogg System Patient Monitoring Cables | Fogg System Company, Inc. | 2023 | 0 | — |
| +7 | K223865 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid… | Edwards Lifesciences, LLC | 2023 | 7 | — |
| +7 | K223651 | Cerebral Adaptive Index (CAI) Algorithm | Edwards Lifesciences, LLC | 2023 | 6 | — |
| +7 | K211619 | Multi-Parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | 2022 | 0 | — |
| +7 | K221833 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module | Edwards Lifesciences, LLC | 2022 | 7 | — |
| +7 | K223127 | HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable | Edwards Lifeciences, LLC | 2022 | 6 | — |
| +7 | K220732 | Mural Perinatal Surveillance | Ge Medical Systems Information Technologies, Inc. | 2022 | 0 | — |
| +7 | K211140 | Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse… | Stryker Sustainability Solutions | 2022 | 2 | — |
| +7 | K212271 | smart-sync | Northh Medical GmbH | 2022 | 0 | — |
| +7 | K203088 | Infinity Acute Care System (IACS) Monitoring System | Draeger Medical Systems, Inc. | 2022 | 1 | 1 |
| +7 | K201764 | Infinity Acute Care System (IACS) Monitoring Solution | Draeger Medical Systems, Inc. | 2021 | 2 | — |
| +7 | K212219 | AHI System | Fifth Eye, Inc. | 2021 | 1 | — |
| +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 | K210086 | Vitals360 Multi-Vitals Mobile Monitor | Vocare, Inc. | 2021 | 4 | — |
| +7 | K203490 | FORE-SIGHT ELITE Absolute Tissue Oximeter | Edwards Lifesciences, LLC | 2021 | 0 | 1 |
| +7 | K201468 | Pulse Oximeter | Shenzhen Creative Industry Co., Ltd. | 2021 | 2 | — |
| +7 | K201746 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies Limited | 2020 | 0 | 7 |
| +7 | K190593 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | 2019 | 4 | — |
| +7 | K183387 | M3290B Patient Information Center iX | Philips Medical Systems | 2019 | 0 | — |
| +7 | K190073 | Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case… | Current Health, Ltd. | 2019 | 18 | — |
| +7 | K182900 | 3880 MRI Patient Monitoring System | Iradimed Corporation | 2018 | 0 | — |