Devices descending from K993637
715 later devices reach N-395 Pulse Oximeter, with Extended Device Claims through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +8 | K241758 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse… | Stryker Sustainability Solutions | 2024 | 0 | — |
| +8 | K233354 | WVSM Pro (Series) (500-0030-XX) | Athena Gtx, Inc. | 2024 | 0 | — |
| +8 | K240251 | ANNE Chest | Sibel Health, Inc. | 2024 | 0 | — |
| +8 | K240305 | ANNE Limb | Sibel Health, Inc. | 2024 | 0 | — |
| +8 | K234130 | Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application… | Ge Medical Systems Information Technologies, Inc. | 2024 | 0 | 4 |
| +8 | K231671 | IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)… | Philips Medizin Systeme Boeblingen GmbH | 2023 | 2 | — |
| +8 | K230612 | Edwards Algorithm for Measurement of Blood Hemoglobin | Edwards Lifesciences, LLC | 2023 | 5 | — |
| +8 | K231477 | Infinity CentralStation Wide, Infinity M300, Infinity M300+ | Draeger Medical Systems, Inc. | 2023 | 1 | — |
| +8 | K230415 | Cadwell Guardian | Cadwell Industries, Inc. | 2023 | 0 | — |
| +8 | K223567 | CNS-2101 Central Monitor | Nihon Kohden Corporation | 2023 | 2 | — |
| +8 | K223578 | T3 Platform software | Etiometry, Inc. | 2023 | 2 | — |
| +8 | K220117 | ARC Intensive Care Information System (ARC System) | Ordinatrum Solutions | 2023 | 0 | — |
| +8 | K223498 | Radius VSM and Accessories | Masimo Corporation | 2023 | 1 | 2 |
| +8 | K212161 | Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories | Masimo Corporation | 2023 | 0 | — |
| +8 | K213423 | T3 Platform software | Etiometry, Inc. | 2023 | 2 | — |
| +8 | K211619 | Multi-Parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | 2022 | 0 | — |
| +8 | K222019 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse… | Stryker Sustainability Solutions | 2022 | 1 | — |
| +8 | K222463 | EchoGo Heart Failure | Ultromics Limited | 2022 | 7 | — |
| +8 | K223246 | Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense | Baxter Healthcare Corproration | 2022 | 0 | — |
| +8 | K211046 | eCareManager 4.5 | Visicu, Inc. | 2022 | 0 | — |
| +8 | K220058 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022 | 3 | 1 |
| +8 | K213335 | Capsule Surveillance System | Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. | 2022 | 3 | — |
| +8 | K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2022 | 5 | — |
| +8 | K210204 | Capsule Vitals Plus Patient Monitoring System | Capsule Technologie Sas | 2021 | 0 | — |
| +8 | K210160 | AlertWatch:AC | Alertwatch, Inc. | 2021 | 0 | — |
| +8 | K203131 | EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2021 | 0 | — |
| +8 | K200717 | CLEWICU System (ClewICUServer and ClewICUnitor) | Clew Medical, Ltd. | 2021 | 12 | — |
| +8 | K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | Edwards Lifesiences, LLC | 2020 | 27 | 1 |
| +8 | K201770 | Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor | Masimo Corporation | 2020 | 1 | 2 |
| +8 | K201432 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2020 | 2 | — |
| +8 | K192757 | VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D… | Vitalconnect, Inc. | 2020 | 1 | — |
| +8 | K191059 | Masimo Rad-97 and Accessories | Masimo Corporation | 2019 | 0 | — |
| +8 | K190270 | FORE-SIGHT ELITE Tissue Oximeter Module | Cas Medical Systems, Inc. | 2019 | 15 | — |
| +8 | K183687 | LifeWindow LW8 Lite | Digicare Biomedical Technology, Inc. | 2019 | 1 | — |
| +8 | K183697 | Masimo Rad-97 and Accessories | Masimo Corporation | 2019 | 9 | — |
| +8 | K181919 | Patient Monitor | Guangdong Biolight Meditech Co., Ltd. | 2019 | 0 | — |
| +8 | K181466 | Cadwell Zenith System | Cadwell Industries, Inc. | 2018 | 0 | — |
| +8 | K180534 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | 2018 | 2 | — |
| +8 | K173715 | AlertWatch:OB | Alertwatch, Inc. | 2018 | 0 | — |
| +8 | K171580 | Monitor B125, Monitor B105 | Ge Medical Systems (China) Co., Ltd. | 2017 | 4 | 1 |
| +8 | K170538 | RVS-100 Vital Signs Monitor | Rudolf Riester GmbH | 2017 | 0 | — |
| +8 | K163649 | SureSigns VS3; SureSigns VS4 | Philips Medical Systems | 2017 | 1 | 10 |
| +8 | K152902 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 6 | 1 |
| +8 | K142209 | Pulse oximeter NBM-200 | Orsense, Ltd. | 2015 | 0 | — |
| +8 | K123690 | CAPNOSTREAM20P with Hifi C02 Monitoring | Oridion Medical 1987, Ltd. | 2014 | 0 | Class I |
| +8 | K131382 | Expression MR200 Mri Patient Monitoring System, Expression IP5 Information Portal | Invivo Corporation | 2013 | 0 | 5 |
| +8 | K124061 | Mri Patient Monitoring System (Model 865214) | Invivo Corporation | 2013 | 4 | 1 |
| +8 | K121424 | Expression Information Portal | Invivo Corporation | 2012 | 2 | 4 |
| +8 | K113798 | Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set | Draeger Medical Systems, Inc. | 2012 | 23 | 8 |
| +8 | K103700 | Essential Mri Patient Monitor | Invivo Corporation | 2011 | 0 | — |
| +9 | K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | 2025 | 0 | — |
| +9 | K251293 | CardioVision | Icardio.Ai | 2025 | 0 | — |
| +9 | K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot… | Philips Medizin Systeme Böblingen GmbH | 2025 | 1 | — |
| +9 | K242728 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025 | 0 | 2 |
| +9 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere… | Edwards Lifesciences | 2025 | 2 | 1 |
| +9 | K242750 | Central Station | Nihon Kohden Digital Health Solutions, LLC | 2025 | 1 | — |
| +9 | K250757 | Radius VSM and Accessories | Masimo Corporation | 2025 | 0 | — |
| +9 | K241958 | WARD-CSS (v1.2.x) | Ward 24/7 Aps | 2025 | 0 | — |
| +9 | K241479 | Etiometry Platform (DAV 5.4 RAE 9.2) | Etiometry, Inc. | 2025 | 1 | — |
| +9 | K240860 | EchoGo Amyloidosis (1.0) | Ultromics Limited | 2024 | 2 | — |
| +9 | K240013 | EchoGo Heart Failure (2.0) | Ultromics Limited | 2024 | 0 | — |
| +9 | K240312 | Infinity CentralStation Wide | Draeger Medical Systems, Inc. | 2024 | 0 | — |
| +9 | K240756 | Aitrics-VC | Aitrics Co., Ltd. | 2024 | 0 | — |
| +9 | K233253 | eCARTv5 Clinical Deterioration Suite (“eCART”) | Agilemd, Inc. | 2024 | 1 | — |
| +9 | K233133 | Talis EMR with Talis +ACG (Talis EMR with +ACG) | Talis Clinical, LLC | 2024 | 0 | — |
| +9 | K232694 | Central Monitoring System (MFM-CMS) | Edan Instruments, Inc. | 2024 | 1 | 1 |
| +9 | K233216 | CLEWICU System | Clew Medical, Ltd. | 2024 | 0 | — |
| +9 | K231531 | Pediarity™ | Hinlab, Inc. | 2023 | 0 | — |
| +9 | K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2023 | 1 | — |
| +9 | K223905 | Vivio® LVEDP System | Avicena, LLC | 2023 | 0 | — |
| +9 | K231335 | Cleerly ISCHEMIA | Cleerly, Inc. | 2023 | 0 | — |
| +9 | K231276 | SmartCardia 7L Platform | Smartcardia SA | 2023 | 0 | — |
| +9 | K231038 | Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences, LLC | 2023 | 6 | — |
| +9 | K221833 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module | Edwards Lifesciences, LLC | 2022 | 7 | — |
| +9 | K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2022 | 1 | — |
| +9 | K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable… | Edwards Lifesciences, LLC | 2022 | 14 | — |
| +9 | K214072 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2022 | 1 | — |
| +9 | K203088 | Infinity Acute Care System (IACS) Monitoring System | Draeger Medical Systems, Inc. | 2022 | 1 | 1 |
| +9 | K201764 | Infinity Acute Care System (IACS) Monitoring Solution | Draeger Medical Systems, Inc. | 2021 | 2 | — |
| +9 | K212219 | AHI System | Fifth Eye, Inc. | 2021 | 1 | — |
| +9 | K212227 | Philips MR Patient Care Portal | Invivo Corporation | 2021 | 0 | 1 |
| +9 | K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X) | Philips Medizin Systeme Boeblingen GmbH | 2021 | 0 | — |
| +9 | K203224 | Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform | Edwards Lifesciences, LLC | 2021 | 1 | — |
| +9 | K211465 | HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform | Edwards Lfesciences | 2021 | 15 | — |
| +9 | K203687 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction… | Edwards Lifesciences, LLC | 2021 | 18 | — |
| +9 | K202189 | Graffiti | Ge Medical Systems Information Technologies, Inc. | 2020 | 0 | — |
| +9 | K193626 | Masimo Rad-97 Pulse CO-Oximeter and Accessories | Masimo Corporation | 2020 | 1 | — |
| +9 | K171901 | uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017 | 0 | — |
| +9 | K160746 | CARDIOLINE touchECG | Cardioline S.P.A | 2016 | 0 | — |
| +9 | K152330 | Expression MR400 MRI Patient Monitoring System | Invivo Corporation | 2015 | 2 | 1 |
| +9 | K132359 | Mri Patient Monitoring System | Invivo Corporation | 2013 | 0 | — |
| +10 | K260008 | Deterioration Index Version 2 | Epic Systems Corporation | 2026 | 0 | — |
| +10 | K260579 | Infinity® Acute Care System (IACS) – VG8.1 | Draeger Medical Systems, Inc. | 2026 | 0 | — |
| +10 | K260211 | Dashboard (P007000) | Hill-Rom, Inc. | 2026 | 0 | — |
| +10 | K250349 | Vista CMS | Shanghai Draeger Medical Instrument Co., Ltd. | 2026 | 0 | — |
| +10 | K254066 | Etiometry Platform | Etiometry, Inc. | 2026 | 0 | — |
| +10 | K253654 | IntelliVue Measurement Rack 6000 (867317) | Philips Medizin Systeme Böblingen GmbH | 2026 | 0 | — |
| +10 | K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026 | 0 | — |
| +10 | K253034 | HemoSphere Stream Module | Edwards Lifesciences | 2025 | 0 | — |
| +10 | K243324 | Masimo O3 Regional Oximeter | Masimo Corporation | 2025 | 0 | — |