Devices descending from K991823
785 later devices reach N-395 Pulse Oximeter, Model N-395 through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +6 | K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2023 | 4 | — |
| +6 | K223574 | IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)… | Philips Medizin Systeme Boeblingen GmbH | 2023 | 2 | — |
| +6 | K231038 | Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences, LLC | 2023 | 6 | — |
| +6 | K222658 | Accurate 24 Non-invasive blood pressure monitor | Accurate Meditech, Inc. | 2023 | 2 | — |
| +6 | K230057 | Acumen Hypotension Prediction Index (HPI) Algorithm | Edwards Lifesciences, LLC | 2023 | 5 | — |
| +6 | K223073 | Alio | Alio, Inc. | 2023 | 0 | — |
| +6 | K223681 | Respiree Cardio-Respiratory Monitor | Respiree Pte, Ltd. | 2023 | 1 | — |
| +6 | K213863 | Everion+ System | Biofourmis Singapore Pte., Ltd. | 2023 | 1 | — |
| +6 | K221348 | IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470) | Philips Medizin Systeme Böblingen GmbH | 2023 | 3 | — |
| +6 | K222010 | Biobeat Platform-2 and BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | 1 | — |
| +6 | K222213 | Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103… | Unimed Medical Supplies, Inc. | 2022 | 0 | — |
| +6 | K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | 2022 | 7 | — |
| +6 | K220351 | Polso Watch | Chronisense Medical, Ltd. | 2022 | 0 | — |
| +6 | K223127 | HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable | Edwards Lifeciences, LLC | 2022 | 6 | — |
| +6 | K222550 | Current Health System | Current Health, Ltd. | 2022 | 1 | — |
| +6 | K220111 | RespiraSense | Pmd Solutions | 2022 | 1 | — |
| +6 | K220530 | Tetragraph Neuromuscular Transmission Monitor | Senzime AB | 2022 | 1 | — |
| +6 | K220308 | Patient Monitor: RespArray | Edan Instruments, Inc. | 2022 | 1 | — |
| +6 | K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable… | Edwards Lifesciences, LLC | 2022 | 14 | — |
| +6 | K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2022 | 2 | 6 |
| +6 | K203113 | Masimo SedLine Sedation Monitor and Accessories | Masimo Corporation | 2022 | 1 | — |
| +6 | K211305 | ANNE One | Sibel, Inc. | 2021 | 6 | — |
| +6 | K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | 2021 | 8 | — |
| +6 | K211588 | Caretaker Platform, VitalStream Platform, CT5 | Caretaker Medical | 2021 | 0 | — |
| +6 | K201887 | VS Newborn Heart Rate Monitor | Surepulse Medical Limited | 2021 | 0 | 5 |
| +6 | K202868 | LifeSignals Multi-Parameter Remote Monitoring Platform | Lifesignals, Inc. | 2021 | 3 | — |
| +6 | K210086 | Vitals360 Multi-Vitals Mobile Monitor | Vocare, Inc. | 2021 | 4 | — |
| +6 | K203490 | FORE-SIGHT ELITE Absolute Tissue Oximeter | Edwards Lifesciences, LLC | 2021 | 0 | 1 |
| +6 | K201468 | Pulse Oximeter | Shenzhen Creative Industry Co., Ltd. | 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 | K202306 | T3 Platform software | Etiometry, Inc. | 2020 | 13 | — |
| +6 | K201941 | Monitor B125, Monitor B105 | Ge Medical Systems Information Technologies, Inc. | 2020 | 3 | — |
| +6 | K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | Edwards Lifesiences, LLC | 2020 | 27 | 1 |
| +6 | K200849 | Tempus LS - Manual | Remote Diagnostic Technologies, Ltd. A Philips Company | 2020 | 0 | 4 |
| +6 | K193415 | physIQ Heart Rhythm and Respiration Module | Physiq, Inc. | 2020 | 0 | — |
| +6 | K191620 | Vitls Platform | Vitls, Inc. | 2020 | 2 | — |
| +6 | K193343 | Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2… | Vitalconnect, Inc. | 2020 | 0 | 1 |
| +6 | K200069 | Disposable SpO2 Sensor | Shenzhen Changke Connect Electronics Co., Ltd. | 2020 | 0 | — |
| +6 | K190734 | Linshom Respiratory Monitoring Device (LRMD) | Linshom Management, LLC | 2020 | 2 | — |
| +6 | K192608 | Disposable SpO2 Sensor | Shenzhen Sino-K Medical Technology Co.,Ltd | 2020 | 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 | K191331 | Life Sensor Cardiac Monitor | Braveheart Wireless, Inc. | 2019 | 0 | — |
| +6 | K182429 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2019 | 3 | — |
| +6 | K183078 | VitalConnect Platform, VitalPatch Biosensor | Vitalconnect, Inc. | 2019 | 9 | — |
| +6 | K180902 | MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly | Medipines Corporation | 2019 | 0 | — |
| +6 | K180482 | ZOLL Propaq M | ZOLL Medical Corporation | 2018 | 2 | — |
| +6 | K173042 | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models… | Edan Instruments, Inc. | 2018 | 1 | 2 |
| +6 | K180003 | FORE-SIGHT ELITE Module Tissue Oximeter | Cas Medical Systems, Inc. | 2018 | 29 | 1 |
| +6 | K171121 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2017 | 16 | — |
| +6 | K172226 | MX40 Release B.07 | Philips Medical Systems | 2017 | 13 | — |
| +6 | K170168 | Masimo Rad-97 and Accessories | Masimo Corporation | 2017 | 14 | — |
| +6 | K171322 | eCareManager 4.1 | Visicu, Inc. | 2017 | 2 | — |
| +6 | K162603 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2017 | 0 | — |
| +6 | K153225 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2016 | 0 | — |
| +6 | K152563 | Pulse Oximeter (MD300M/MD300K2) | Beijing Choice Electronic Technology Co., Ltd. | 2016 | 8 | — |
| +6 | K153335 | AlertWatch: OR | Alertwatch, LLC | 2016 | 1 | — |
| +6 | K153448 | Passport Series Patient Monitors (Including Passport 8, Passport 12) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 0 | 2 |
| +6 | K151812 | Patient Monitors Various Models | Philips Medical Systems | 2016 | 0 | — |
| +6 | K151287 | Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D | Guangdong Biolight Meditech Co., Ltd. | 2016 | 0 | — |
| +6 | K152341 | ViSi Mobile Monitoring System | Sotera Wireless, Inc. | 2015 | 4 | — |
| +6 | K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2015 | 24 | — |
| +6 | K151736 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boblingen GmbH | 2015 | 24 | — |
| +6 | K150082 | Panorama Patient Monitoring Network | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 0 | 1 |
| +6 | K150352 | V Series Monitoring System (including V12 and V21 Monitors) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 1 | — |
| +6 | K151776 | Central Venous Pressure System | Mespere Lifesciences, Inc. | 2015 | 0 | — |
| +6 | K150198 | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel | Bio-Detek, Inc. | 2015 | 0 | — |
| +6 | K150361 | ViSi Mobile Monitoring System | Sotera Wireless, Inc. | 2015 | 6 | — |
| +6 | K141362 | Pulse Oximeter CMS50EW | Contec Medical Systems Co.,Ltd | 2015 | 1 | — |
| +6 | K142106 | Decisio Health Patient Dashboard | Decisio Health, Inc. | 2015 | 5 | — |
| +6 | K133239 | Zoll E Series | Zoll Medical Corporation, World Wide Headquarters | 2015 | 0 | — |
| +6 | K143195 | Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2014 | 9 | 1 |
| +6 | K143057 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2014 | 4 | 1 |
| +6 | K142915 | ZOLL X Series | ZOLL Medical Corporation | 2014 | 0 | — |
| +6 | K140535 | Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50 | Philips Medizin Systeme Boblingen GmbH | 2014 | 0 | 5 |
| +6 | K141774 | Zoll X Series | ZOLL Medical Corporation | 2014 | 2 | — |
| +6 | K133441 | Onestep CPR II Multi-Function Electrode | Bio-Detek, Inc. | 2014 | 1 | — |
| +6 | K133961 | Suresigns VS3, Suresigns VS4 | Philips Medical Systems | 2014 | 3 | — |
| +6 | K132320 | Intellivue CL Respiration Pod | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2014 | 20 | — |
| +6 | K133576 | Monitor B40 | Ge Medical Systems China Co., Ltd. | 2014 | 7 | Class I |
| +6 | K131032 | Philips Suresigns Central | Philips Medical Systems | 2013 | 1 | — |
| +6 | K130170 | Exspiron 1XI | Respiratory Motion, Inc. | 2013 | 4 | — |
| +6 | K120984 | Masimo Ras-125C Acoustic Respiration Sensor | Masimo Corporation | 2013 | 2 | — |
| +6 | K123900 | Suresigns VM4, Suresigns VM6, Suresigns VM8 | Philips Medical Systems | 2013 | 5 | 2 |
| +6 | K130056 | Patient Monitor | Ld Technology, LLC | 2013 | 0 | — |
| +6 | K123472 | Cimva Universal | Therapeutic Monitoring Systems (Tms), Inc. | 2013 | 0 | — |
| +6 | K120907 | Zoll R Series | Zoll Medical Corporation, World Wide Headquarters | 2012 | 6 | — |
| +6 | K113833 | Vital Signs Monitor | Guangdong Biolight Meditech Co., Ltd. | 2012 | 3 | — |
| +6 | K112804 | Fingertip Pulse Oximeter | Guangdong Biolight Meditech Co., Ltd. | 2012 | 0 | — |
| +6 | K113125 | Intellivue MX40 Patient Monitor | Philips Medical Systems | 2011 | 14 | 16 |
| +6 | K110516 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | 67 | — |
| +6 | K110361 | Zoll R Series with 2010 Aha Guidelines Software Update | Zoll Medical Corporation, World Wide Headquarters | 2011 | 7 | — |
| +6 | K101995 | Capnostream 20P with Masimo SPO2 Board | Oridion Capnography, Inc. | 2011 | 7 | — |
| +6 | K101694 | Handheld Pulse Oximeter Model M800 | Guangdong Biolight Meditech Co., Ltd. | 2010 | 0 | — |
| +6 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | 115 | — |
| +6 | K081937 | Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry… | Philips Medizin Systeme Boeblingen GmbH | 2008 | 49 | — |
| +7 | K254000 | Happy Health Blood Pressure Monitor | Happy Health, Inc. | 2026 | 0 | — |
| +7 | K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus… | Empatica S.r.l. | 2026 | 0 | — |
| +7 | K260880 | SedLine Sedation Monitor | Masimo Corporation | 2026 | 0 | — |