510(k) Report

Devices descending from K910772

435 later devices reach Propaq 102, 104 and 106 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc.20160—
+10K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+10K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+10K142915ZOLL X SeriesZOLL Medical Corporation20140—
+10K141774Zoll X SeriesZOLL Medical Corporation20142—
+10K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+10K132808Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc.20136—
+10K124041NBM-200MPOrsense, Ltd.20131—
+10K112368CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd.201266
+10K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+10K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation201189—
+11K250837Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20250—
+11K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+11K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+11K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+11K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+11K232975Pulse Oximeter (MD300C228)Beijing Choice Electronic Technology Co., Ltd.20240—
+11K232445CSF-4 (CSF-4)Cardiacsense20240—
+11K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+11K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+11K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+11K230172Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20231—
+11K230823AusculThing ACCAusculthing OY20230—
+11K220101Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20230—
+11K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+11K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+11K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+11K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+11K220351Polso WatchChronisense Medical, Ltd.20220—
+11K212473Welch Allyn Connex Central StationWelch Allyn, Inc.20220—
+11K220766eMurmur Heart AICsd Labs GmbH20221—
+11K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+11K202375ZOLL Propaq MZOLL Medical Corporation20211—
+11K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and…Hill-Rom, Inc.20211—
+11K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+11K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+11K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+11K191925MATRx PlusZephyr Sleep Technologies20191—
+11K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+11K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+11K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+11K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+11K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+11K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+11K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+11K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+11K172890SedLine Sedation MonitorMasimo Corporation20185—
+11K170497V10Mediana Co., Ltd.201711
+11K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+11K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+11K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+11K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+11K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+11K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+11K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd.20140Class I
+11K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+11K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201166—
+12K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+12K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+12K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+12K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+12K252981EmbraceMiniEmpatica S.r.l.20251—
+12K252284eMurmur Heart AICsd Labs20250—
+12K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+12K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+12K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+12K243049Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)Hunan Accurate Bio-Medical Technology Co., Ltd.20250—
+12K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+12K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+12K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+12K232915EpiMonitorEmpatica S.r.l.20241—
+12K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+12K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+12K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+12K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+12K223246Hillrom Heart and Respiration Rate Monitoring System powered by EarlySenseBaxter Healthcare Corproration20220—
+12K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+12K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+12K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+12K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+12K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+12K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+12K200695MATRx plusZephyr Sleep Technologies20200—
+12K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+12K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+12K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+12K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+12K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+12K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+13K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+13K260880SedLine Sedation MonitorMasimo Corporation20260—
+13K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+13K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+13K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+13K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+13K250515EpiMonitorEmpatica S.r.l.20250—
+13K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+13K241397HinscopeHinlab Sas20240—
+13K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+13K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—