510(k) Report

Devices descending from K993637

715 later devices reach N-395 Pulse Oximeter, with Extended Device Claims through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K253436c-med0 alphaCosinuss GmbH20260—
+6K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+6K244007ArteVuCardio Ring Technologies, Inc. Taiwan Branch20250—
+6K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+6K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+6K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+6K241397HinscopeHinlab Sas20240—
+6K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+6K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+6K240558NavoycdsAlgodx AB20240—
+6K232445CSF-4 (CSF-4)Cardiacsense20240—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+6K231625VitalDetectWellvii, Inc.20240—
+6K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+6K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+6K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+6K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+6K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+6K223073AlioAlio, Inc.20230—
+6K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+6K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+6K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+6K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+6K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+6K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+6K220351Polso WatchChronisense Medical, Ltd.20220—
+6K222550Current Health SystemCurrent Health, Ltd.20221—
+6K220111RespiraSensePmd Solutions20221—
+6K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+6K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+6K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+6K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+6K211305ANNE OneSibel, Inc.20216—
+6K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+6K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+6K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited202105
+6K202868LifeSignals Multi-Parameter Remote Monitoring PlatformLifesignals, Inc.20213—
+6K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+6K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+6K202336Patient MonitorEdan Instruments, Inc.202131
+6K202306T3 Platform softwareEtiometry, Inc.202013—
+6K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+6K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+6K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+6K193415physIQ Heart Rhythm and Respiration ModulePhysiq, Inc.20200—
+6K191620Vitls PlatformVitls, Inc.20202—
+6K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2…Vitalconnect, Inc.202001
+6K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+6K191331Life Sensor Cardiac MonitorBraveheart Wireless, Inc.20190—
+6K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+6K183078VitalConnect Platform, VitalPatch BiosensorVitalconnect, Inc.20199—
+6K180902MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable AssemblyMedipines Corporation20190—
+6K180482ZOLL Propaq MZOLL Medical Corporation20182—
+6K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+6K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+6K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+6K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+6K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…Hill-Rom, Inc.20182—
+6K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH20177—
+6K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+6K172226MX40 Release B.07Philips Medical Systems201713—
+6K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+6K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+6K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+6K153156eCareManager 4.0.1Visicu, Inc.20163—
+6K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+6K160526Masimo O3 Regional Oximeter SystemMasimo Corporation20165—
+6K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+6K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+6K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+6K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+6K152341ViSi Mobile Monitoring SystemSotera Wireless, Inc.20154—
+6K150268CerOXOr-Nim Medical, Ltd.20150—
+6K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+6K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+6K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+6K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+6K151776Central Venous Pressure SystemMespere Lifesciences, Inc.20150—
+6K150512STAR 90Skanray Technologies Pvt, Ltd.20151—
+6K150198CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelBio-Detek, Inc.20150—
+6K150361ViSi Mobile Monitoring SystemSotera Wireless, Inc.20156—
+6K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+6K143675FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc.2015371
+6K133239Zoll E SeriesZoll Medical Corporation, World Wide Headquarters20150—
+6K142915ZOLL X SeriesZOLL Medical Corporation20140—
+6K141774Zoll X SeriesZOLL Medical Corporation20142—
+6K133441Onestep CPR II Multi-Function ElectrodeBio-Detek, Inc.20141—
+6K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+6K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America201410—
+6K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+6K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+6K130401Alertwatch: orAlertwatch, LLC20148—
+6K120984Masimo Ras-125C Acoustic Respiration SensorMasimo Corporation20132—
+6K123900Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems201352
+6K130056Patient MonitorLd Technology, LLC20130—
+6K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+6K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters20126—
+6K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+6K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+6K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—