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 |
|---|---|---|---|---|---|---|
| +7 | K100617 | Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20D | Masimo Corporation | 2010 | 39 | — |
| +7 | K094046 | LNCS Oximetry Sensors, Reprocessed LNCS Oximetry Sensors | Masimo Corporation | 2010 | 0 | — |
| +7 | K090662 | Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ Dbip | Masimo Corporation | 2009 | 1 | 1 |
| +8 | K260008 | Deterioration Index Version 2 | Epic Systems Corporation | 2026 | 0 | — |
| +8 | K260226 | ElintMAX Respiratory Monitor (ElintMAX Monitor A1) | Amptron Medical, Inc. | 2026 | 0 | — |
| +8 | K260579 | Infinity® Acute Care System (IACS) – VG8.1 | Draeger Medical Systems, Inc. | 2026 | 0 | — |
| +8 | K251326 | Respiration Rate algorithm | Edwards Lifesciences, LLC | 2026 | 0 | — |
| +8 | K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026 | 0 | — |
| +8 | K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | 2025 | 0 | — |
| +8 | K253034 | HemoSphere Stream Module | Edwards Lifesciences | 2025 | 0 | — |
| +8 | K242728 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025 | 0 | 2 |
| +8 | K242750 | Central Station | Nihon Kohden Digital Health Solutions, LLC | 2025 | 1 | — |
| +8 | K241397 | Hinscope | Hinlab Sas | 2024 | 0 | — |
| +8 | K240596 | Cerebral Autoregulation Index (CAI) Algorithm | Edwards Lifesciences | 2024 | 0 | — |
| +8 | K233984 | Acumen Assisted Fluid Management (AFM) Software Feature | Edwards Lifesciences, LLC | 2024 | 0 | — |
| +8 | K240312 | Infinity CentralStation Wide | Draeger Medical Systems, Inc. | 2024 | 0 | — |
| +8 | K232111 | NeoBeat, NeoBeat Mini | Laerdal Medical AS | 2024 | 0 | — |
| +8 | K232694 | Central Monitoring System (MFM-CMS) | Edan Instruments, Inc. | 2024 | 1 | 1 |
| +8 | K230612 | Edwards Algorithm for Measurement of Blood Hemoglobin | Edwards Lifesciences, LLC | 2023 | 5 | — |
| +8 | K230842 | SignalHF (IM008) | Implicity, Inc. | 2023 | 0 | — |
| +8 | K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced… | Edwards Lifesciencess, LLC | 2023 | 6 | 2 |
| +8 | K213863 | Everion+ System | Biofourmis Singapore Pte., Ltd. | 2023 | 1 | — |
| +8 | K222019 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse… | Stryker Sustainability Solutions | 2022 | 1 | — |
| +8 | K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | 2022 | 7 | — |
| +8 | K222550 | Current Health System | Current Health, Ltd. | 2022 | 1 | — |
| +8 | K220308 | Patient Monitor: RespArray | Edan Instruments, Inc. | 2022 | 1 | — |
| +8 | K221203 | AHI System | Fifth Eye, Inc. | 2022 | 0 | — |
| +8 | K220732 | Mural Perinatal Surveillance | Ge Medical Systems Information Technologies, Inc. | 2022 | 0 | — |
| +8 | K212227 | Philips MR Patient Care Portal | Invivo Corporation | 2021 | 0 | 1 |
| +8 | K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | 2021 | 8 | — |
| +8 | K202336 | Patient Monitor | Edan Instruments, Inc. | 2021 | 3 | 1 |
| +8 | K192595 | ExSpiron 2Xi | Respiratory Motion | 2019 | 0 | — |
| +8 | K183387 | M3290B Patient Information Center iX | Philips Medical Systems | 2019 | 0 | — |
| +8 | K191018 | Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors | Surgical Instrument Service and Savings, Inc. | 2019 | 0 | — |
| +8 | K172141 | Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. | 2018 | 0 | — |
| +8 | K173203 | Athena GTX Device Management Suite (ADMS) Software | Athena Gtx | 2018 | 0 | — |
| +8 | K162199 | Cascade IOMAX Intraoperative Monitor | Cadwell Industries, Inc. | 2017 | 7 | 3 |
| +8 | K153135 | Vital Signs Monitor | Guangdong Biolight Meditech Co., Ltd. | 2016 | 2 | — |
| +8 | K152330 | Expression MR400 MRI Patient Monitoring System | Invivo Corporation | 2015 | 2 | 1 |
| +8 | K150869 | Checkme Pro Health Monitor | Viatom Technology Co., Ltd. | 2015 | 5 | — |
| +8 | K140430 | 740 Select | Cas Medical Systems, Inc. | 2014 | 1 | — |
| +8 | K132359 | Mri Patient Monitoring System | Invivo Corporation | 2013 | 0 | — |
| +8 | K121912 | E1 Ear Sensors | Masimo Corporation | 2012 | 4 | — |
| +8 | K113596 | Masimo Set Reusable Oximetry Sensors | Masimo Corporation | 2012 | 0 | — |
| +8 | K111621 | Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry Sensors | Masimo Corporation | 2011 | 38 | — |
| +8 | K111888 | Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry Sensors | Masimo Corporation | 2011 | 59 | — |
| +9 | K263010 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | inomed Medizintechnik GmbH | 2026 | 0 | — |
| +9 | K260211 | Dashboard (P007000) | Hill-Rom, Inc. | 2026 | 0 | — |
| +9 | K250349 | Vista CMS | Shanghai Draeger Medical Instrument Co., Ltd. | 2026 | 0 | — |
| +9 | K242909 | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | Edwards Lifesciences, LLC | 2025 | 0 | — |
| +9 | K241758 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse… | Stryker Sustainability Solutions | 2024 | 0 | — |
| +9 | K240320 | Patient Monitor (RespArray) | Edan Instruments, Inc. | 2024 | 0 | — |
| +9 | K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. | 2024 | 0 | — |
| +9 | K232962 | Patient Monitor (iX10, iX12, iX15) | Edan Instruments, Inc. | 2024 | 2 | 1 |
| +9 | K232548 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2024 | 1 | — |
| +9 | K232915 | EpiMonitor | Empatica S.r.l. | 2024 | 1 | — |
| +9 | K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2023 | 4 | — |
| +9 | K231506 | Current Health System | Current Health, Ltd. | 2023 | 0 | — |
| +9 | K230415 | Cadwell Guardian | Cadwell Industries, Inc. | 2023 | 0 | — |
| +9 | K212271 | smart-sync | Northh Medical GmbH | 2022 | 0 | — |
| +9 | K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2022 | 5 | — |
| +9 | K201635 | MouthLab Vital Signs Monitoring System | Multisensor Diagnostics (Dba Aidar Health) | 2021 | 0 | — |
| +9 | K191088 | Checkme O2 Pulse Oximeter | Shenzhen Viatom Technology Co., Ltd. | 2019 | 2 | — |
| +9 | K190090 | DynoSense Vital Sign Measuring System | Dynosense Corp. | 2019 | 0 | — |
| +9 | K181919 | Patient Monitor | Guangdong Biolight Meditech Co., Ltd. | 2019 | 0 | — |
| +9 | K182900 | 3880 MRI Patient Monitoring System | Iradimed Corporation | 2018 | 0 | — |
| +9 | K181466 | Cadwell Zenith System | Cadwell Industries, Inc. | 2018 | 0 | — |
| +9 | K170538 | RVS-100 Vital Signs Monitor | Rudolf Riester GmbH | 2017 | 0 | — |
| +9 | K153184 | Caremed Reusable & Disposable SPO2 Sensors | Shenzhen Caremed Medical Technology Co., Ltd. | 2017 | 5 | — |
| +9 | K150620 | 740 Select | Cas Medical Systems, Inc. | 2015 | 0 | 1 |
| +9 | K142832 | Unimed Disposable and Reusable SPO2 Sensors | Unimed Medical Supplies, Inc. | 2015 | 14 | — |
| +9 | K122996 | Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085 | Xhale | 2013 | 3 | — |
| +10 | K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus… | Empatica S.r.l. | 2026 | 0 | — |
| +10 | K261367 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2026 | 0 | — |
| +10 | 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 | — |
| +10 | K253109 | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) | Shenzhen Best Electronics Co., Ltd. | 2026 | 0 | — |
| +10 | K252981 | EmbraceMini | Empatica S.r.l. | 2025 | 1 | — |
| +10 | K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2… | Unimed Medical Supplies, Inc. | 2025 | 0 | — |
| +10 | K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08… | Unimed Medical Supplies, Inc. | 2025 | 0 | — |
| +10 | K251695 | Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06… | Unimed Medical Supplies, Inc. | 2025 | 0 | — |
| +10 | K251693 | Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75… | Unimed Medical Supplies, Inc. | 2025 | 0 | — |
| +10 | K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | Edan Instruments, Inc. | 2025 | 0 | — |
| +10 | K250515 | EpiMonitor | Empatica S.r.l. | 2025 | 0 | — |
| +10 | K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2025 | 0 | — |
| +10 | K242876 | Pulse Oximeter ( PO2, PO2A, PO2B) | Shenzhen Viatom Technology Co., Ltd. | 2025 | 0 | — |
| +10 | K242580 | Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2… | Unimed Medical Supplies, Inc. | 2025 | 1 | — |
| +10 | K240236 | Happy Ring Health Monitoring System | Happy Health, Inc. | 2024 | 0 | — |
| +10 | K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2023 | 1 | — |
| +10 | K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2022 | 1 | — |
| +10 | K213515 | WesperO2 | Wesper, Inc. | 2022 | 0 | — |
| +10 | K202851 | Spo2 Sensor | Jkh USA, LLC | 2020 | 1 | — |
| +10 | K201360 | Reusable and Disposable SpO2 Sensors | Xinkang Medical Instrument Co., Ltd. | 2020 | 1 | — |
| +10 | K191279 | Disposable SpO2 Sensor | Shenzhen Caremed Medical Technology Co., Ltd. | 2019 | 1 | — |
| +10 | K191420 | Reusable SpO2 Sensor | Shenzhen Changke Connect Electronics Co., Ltd. | 2019 | 0 | — |
| +10 | K181270 | Disposable SpO2 Sensors, Reusable SpO2 Sensors | Orantech, Inc. | 2018 | 1 | — |
| +10 | K173368 | Reusable & Disposable SpO2 Sensors | Shenzhen Coreray Technology, Ltd. | 2018 | 0 | — |
| +10 | K172981 | Reusable SpO2 Sensors, Disposable SpO2 Sensors | APK Technology Co., Ltd. | 2018 | 0 | — |
| +10 | K173045 | Oximeter | Shenzhen Greatmade Tech Limited | 2018 | 0 | — |
| +10 | K143216 | Assurance Alar / Nasal SpO2 Sensor | Xhale, Inc. | 2015 | 2 | 1 |
| +11 | K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) | Unimed Medical Supplies, Inc. | 2026 | 0 | — |