Devices descending from K013427
407 later devices reach Modification to:Philips M3000A/M3046A Compact Portable Patient Monitor, Models… through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +6 | K173715 | AlertWatch:OB | Alertwatch, Inc. | 2018 | 0 | — |
| +6 | K162131 | ExSpiron 1Xi | Respiratory Motion, Inc. | 2017 | 3 | — |
| +6 | K160981 | Patient Monitor | Edan Instruments, Inc. | 2016 | 8 | 1 |
| +6 | K153702 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2016 | 3 | 12 |
| +6 | K160951 | Philips Efficia CMS200 Central Monitoring System | Philips Medical Systems | 2016 | 0 | 1 |
| +6 | K152902 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 6 | 1 |
| +6 | K132077 | Patient Monitor | Advanced Instrumentations, Inc. | 2014 | 0 | — |
| +6 | K131971 | IM60/IM70 Patient Monitor | Edan Instruments, Inc. | 2014 | 14 | 2 |
| +6 | K132033 | BM3/BM3 Plus | Noblitt & Rueland | 2013 | 0 | — |
| +6 | K123048 | Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A Pro | Advanced Instrumentations, Inc. | 2013 | 0 | — |
| +6 | K113798 | Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set | Draeger Medical Systems, Inc. | 2012 | 23 | 8 |
| +6 | K103285 | Dixtal DZ-4100 Series Pulse Oximeter | Dixtal Medical, Inc. | 2011 | 0 | — |
| +6 | K110922 | Patient Monitor | Edan Instruments, Inc. | 2011 | 1 | 1 |
| +6 | K101692 | Patient Monitor | Contec Medical System Co., Ltd. | 2011 | 0 | 1 |
| +6 | K102958 | Philips Avalon Fetal Monitor | Philips Medizin Systeme Boblingen GmbH | 2011 | 2 | — |
| +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 | K100420 | Philips Obtracevue Model SW Rev. G.00 | Philips Medizin Systeme Boeblingen GmbH | 2010 | 4 | — |
| +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 | K090785 | Mri Compatible Patient Monitoring System, Model 865214 | Invivo Corp. | 2009 | 9 | 6 |
| +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 | K083622 | LNCS Oximetry Sensors | Masimo Corporation | 2009 | 1 | — |
| +6 | K082888 | Infinity Nellcor Oximax Smartpod, Model MS23997 | Draeger Medical Systems, Inc. | 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 | K251508 | Telemetry Monitor (iT30, iT50) | Edan Instruments, Inc. | 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 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere… | Edwards Lifesciences | 2025 | 2 | 1 |
| +7 | K242518 | Hypertension Prediction Index (HePI) Algorithm | Edwards Lifesciences, LLC | 2025 | 0 | — |
| +7 | K242962 | Telemetry Monitor 5500 Release 4.0 (867232) | Philips Medizin Systeme Böblingen GmbH | 2025 | 0 | 1 |
| +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 | K240756 | Aitrics-VC | Aitrics Co., Ltd. | 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 | K232035 | Impala | AliveCor, Inc. | 2024 | 0 | — |
| +7 | K233133 | Talis EMR with Talis +ACG (Talis EMR with +ACG) | Talis Clinical, LLC | 2024 | 0 | — |
| +7 | K233216 | CLEWICU System | Clew Medical, Ltd. | 2024 | 0 | — |
| +7 | K231477 | Infinity CentralStation Wide, Infinity M300, Infinity M300+ | Draeger Medical Systems, Inc. | 2023 | 1 | — |
| +7 | K223567 | CNS-2101 Central Monitor | Nihon Kohden Corporation | 2023 | 2 | — |
| +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 | 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 | 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 | K221616 | Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17 | Caf Medical Solutions, Inc. | 2022 | 0 | — |
| +7 | K212975 | MedWand | Medwand Solutions, Inc. | 2022 | 1 | — |
| +7 | K220058 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022 | 3 | 1 |
| +7 | K211140 | Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse… | Stryker Sustainability Solutions | 2022 | 2 | — |
| +7 | K212300 | Pulse Oximeter | Shenzhen Mericonn Technology Co., Ltd. | 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 | K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X) | Philips Medizin Systeme Boeblingen GmbH | 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 | K203490 | FORE-SIGHT ELITE Absolute Tissue Oximeter | Edwards Lifesciences, LLC | 2021 | 0 | 1 |
| +7 | K202189 | Graffiti | Ge Medical Systems Information Technologies, Inc. | 2020 | 0 | — |
| +7 | K192952 | Spire Health Remote Patient Monitoring System | Spire, Inc. D/B/A Spire Health | 2020 | 0 | — |
| +7 | K192514 | Patient Monitor | Edan Instruments, Inc. | 2020 | 6 | 1 |
| +7 | K191272 | Wearable Device, Wearable Package | Current Health, Ltd. | 2019 | 16 | — |
| +7 | K173941 | IntelliSpace Perinatal Rev.K.00 | Philips Medizin Systeme Boeblingen GmbH | 2018 | 1 | — |
| +7 | K173181 | ExSpiron 1Xi | Respiratory Motion, Inc. | 2018 | 2 | — |
| +7 | K171901 | uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017 | 0 | — |
| +7 | K163584 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2017 | 2 | — |
| +7 | K161056 | Telemetry Transmitter | Edan Instruments, Inc. | 2017 | 0 | 2 |
| +7 | K160746 | CARDIOLINE touchECG | Cardioline S.P.A | 2016 | 0 | — |
| +7 | K152563 | Pulse Oximeter (MD300M/MD300K2) | Beijing Choice Electronic Technology Co., Ltd. | 2016 | 8 | — |
| +7 | K151287 | Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D | Guangdong Biolight Meditech Co., Ltd. | 2016 | 0 | — |
| +7 | K141362 | Pulse Oximeter CMS50EW | Contec Medical Systems Co.,Ltd | 2015 | 1 | — |
| +7 | K131762 | Handheld Monitor | Guangdong Biolight Meditech Co., Ltd. | 2014 | 7 | — |
| +7 | K131876 | M Series Patient Monitor | Mid-Link Consulting Co, Ltd. | 2014 | 0 | — |
| +7 | K131382 | Expression MR200 Mri Patient Monitoring System, Expression IP5 Information Portal | Invivo Corporation | 2013 | 0 | 5 |
| +7 | K131763 | Truscope Series Patient Monitor | Guangdong Biolight Meditech Co., Ltd. | 2013 | 0 | — |
| +7 | K130056 | Patient Monitor | Ld Technology, LLC | 2013 | 0 | — |
| +7 | K124061 | Mri Patient Monitoring System (Model 865214) | Invivo Corporation | 2013 | 4 | 1 |
| +7 | K120657 | Masimo Set and Masimo Rainbow Set Pulse Oximeters and Sensors | Masimo Corporation | 2012 | 37 | — |
| +7 | K121424 | Expression Information Portal | Invivo Corporation | 2012 | 2 | 4 |
| +7 | K120631 | Patient Monitor | Advanced Instruments, Inc. | 2012 | 0 | — |
| +7 | K113833 | Vital Signs Monitor | Guangdong Biolight Meditech Co., Ltd. | 2012 | 3 | — |
| +7 | K112804 | Fingertip Pulse Oximeter | Guangdong Biolight Meditech Co., Ltd. | 2012 | 0 | — |
| +7 | K112803 | Patient Monitor | Guangdong Biolight Meditech Co., Ltd. | 2011 | 0 | — |
| +7 | K110723 | M-LNCS Oximetry Sensors, Reprocessed M-LNCS Oximetry Sensors | Masimo Corporation | 2011 | 0 | — |
| +7 | K103700 | Essential Mri Patient Monitor | Invivo Corporation | 2011 | 0 | — |
| +7 | K101031 | Masimo Disposable Oximetry Ear Sensor, Model E1 | Masimo Corporation | 2010 | 5 | — |
| +7 | K101896 | Masimo LNCS/M-LNCS Oximetry Sensors | Masimo Corporation | 2010 | 62 | — |
| +7 | K102040 | Patient Monitor | Guangdong Biolight Meditech Co., Ltd. | 2010 | 1 | — |
| +7 | K101694 | Handheld Pulse Oximeter Model M800 | Guangdong Biolight Meditech Co., Ltd. | 2010 | 0 | — |