510(k) Report

Devices descending from K982255

816 later devices reach Model 2000 Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K202868LifeSignals Multi-Parameter Remote Monitoring PlatformLifesignals, Inc.20213—
+7K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+7K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+7K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+7K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+7K202336Patient MonitorEdan Instruments, Inc.202131
+7K202306T3 Platform softwareEtiometry, Inc.202013—
+7K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+7K193415physIQ Heart Rhythm and Respiration ModulePhysiq, Inc.20200—
+7K191620Vitls PlatformVitls, Inc.20202—
+7K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+7K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2…Vitalconnect, Inc.202001
+7K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+7K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+7K191331Life Sensor Cardiac MonitorBraveheart Wireless, Inc.20190—
+7K182429Masimo O3 Regional Oximeter SystemMasimo Corporation20193—
+7K183078VitalConnect Platform, VitalPatch BiosensorVitalconnect, Inc.20199—
+7K180902MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable AssemblyMedipines Corporation20190—
+7K180482ZOLL Propaq MZOLL Medical Corporation20182—
+7K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+7K180017MX40 Release C.01Philips Medical Systems20181—
+7K180003FORE-SIGHT ELITE Module Tissue OximeterCas Medical Systems, Inc.2018291
+7K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…Hill-Rom, Inc.20182—
+7K173715AlertWatch:OBAlertwatch, Inc.20180—
+7K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+7K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+7K162603Masimo O3 Regional Oximeter SystemMasimo Corporation20170—
+7K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+7K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+7K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+7K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+7K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+7K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+7K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+7K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+7K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+7K152341ViSi Mobile Monitoring SystemSotera Wireless, Inc.20154—
+7K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+7K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+7K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+7K151776Central Venous Pressure SystemMespere Lifesciences, Inc.20150—
+7K150198CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelBio-Detek, Inc.20150—
+7K150361ViSi Mobile Monitoring SystemSotera Wireless, Inc.20156—
+7K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+7K133239Zoll E SeriesZoll Medical Corporation, World Wide Headquarters20150—
+7K142915ZOLL X SeriesZOLL Medical Corporation20140—
+7K141774Zoll X SeriesZOLL Medical Corporation20142—
+7K133441Onestep CPR II Multi-Function ElectrodeBio-Detek, Inc.20141—
+7K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+7K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+7K120984Masimo Ras-125C Acoustic Respiration SensorMasimo Corporation20132—
+7K123900Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems201352
+7K130056Patient MonitorLd Technology, LLC20130—
+7K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters20126—
+7K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+7K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+7K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+7K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+7K110361Zoll R Series with 2010 Aha Guidelines Software UpdateZoll Medical Corporation, World Wide Headquarters20117—
+7K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc.20117—
+7K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+7K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010115—
+7K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+8K260008Deterioration Index Version 2Epic Systems Corporation20260—
+8K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+8K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+8K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+8K260880SedLine Sedation MonitorMasimo Corporation20260—
+8K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+8K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+8K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+8K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+8K252981EmbraceMiniEmpatica S.r.l.20251—
+8K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+8K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+8K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+8K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+8K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+8K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+8K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+8K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+8K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+8K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+8K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+8K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+8K240756Aitrics-VCAitrics Co., Ltd.20240—
+8K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+8K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+8K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+8K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+8K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+8K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+8K232915EpiMonitorEmpatica S.r.l.20241—
+8K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+8K230842SignalHF (IM008)Implicity, Inc.20230—
+8K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+8K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+8K231506Current Health SystemCurrent Health, Ltd.20230—
+8K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+8K223711ANNE OneSibel Health, Inc.20234—