510(k) Report

Devices descending from K900032

489 later devices reach Model M1175A/M1176A with ST Segment Monitoring through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K230842SignalHF (IM008)Implicity, Inc.20230—
+8K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+8K222330The Heart SeatCasana Care, Inc.20230—
+8K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+8K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+8K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+8K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+8K222550Current Health SystemCurrent Health, Ltd.20221—
+8K212975MedWandMedwand Solutions, Inc.20221—
+8K221203AHI SystemFifth Eye, Inc.20220—
+8K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+8K211754Vital Signs MonitorBeijing Choice Electronic Technology Co., Ltd.20210—
+8K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+8K192595ExSpiron 2XiRespiratory Motion20190—
+8K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+8K191018Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive SensorsSurgical Instrument Service and Savings, Inc.20190—
+8K183238BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201911—
+8K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+8K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+8K170182Cardiovit FT-1Schiller AG20170—
+8K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+8K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+8K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+8K140430740 SelectCas Medical Systems, Inc.20141—
+8K132037Vital Signs MonitorMindray North America201432
+8K132038Accutorr 7 Vital Signs MonitorMindray North America20142—
+8K121912E1 Ear SensorsMasimo Corporation20124—
+8K113596Masimo Set Reusable Oximetry SensorsMasimo Corporation20120—
+8K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation201138—
+8K111888Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation201159—
+9K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+9K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+9K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+9K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+9K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+9K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+9K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+9K232915EpiMonitorEmpatica S.r.l.20241—
+9K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+9K231506Current Health SystemCurrent Health, Ltd.20230—
+9K230415Cadwell GuardianCadwell Industries, Inc.20230—
+9K221113Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+9K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+9K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+9K202892Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc.202111
+9K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+9K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+9K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+9K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+9K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+9K170712Accutorr 7/VS-900 Vital Signs MonitorShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201711
+9K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.20175—
+9K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.201514—
+9K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale20133—
+10K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+10K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+10K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd.20260—
+10K252981EmbraceMiniEmpatica S.r.l.20251—
+10K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+10K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…Unimed Medical Supplies, Inc.20250—
+10K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…Unimed Medical Supplies, Inc.20250—
+10K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…Unimed Medical Supplies, Inc.20250—
+10K250515EpiMonitorEmpatica S.r.l.20250—
+10K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+10K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+10K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc.20251—
+10K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+10K233038Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc.202401
+10K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+10K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+10K213515WesperO2Wesper, Inc.20220—
+10K202851Spo2 SensorJkh USA, LLC20201—
+10K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+10K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+10K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+10K182821Accutorr 7/VS-900/VS-900c Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.201901
+10K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+10K173368Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd.20180—
+10K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+10K173045OximeterShenzhen Greatmade Tech Limited20180—
+10K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+11K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+11K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+11K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+11K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+11K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20200—
+11K192608Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd20200—
+11K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+12K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—