510(k) Report

Devices descending from K951370

442 later devices reach Zymed Telemetry System; Model T8010 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+8K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+8K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+8K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+8K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+8K240156LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV…Physio-Control, Inc.20240—
+8K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+8K231625VitalDetectWellvii, Inc.20240—
+8K222712Fogg System Patient Monitoring CablesFogg System Company, Inc.20230—
+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
+8K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+8K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+8K221203AHI SystemFifth Eye, Inc.20220—
+8K220732Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc.20220—
+8K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+8K211140Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse…Stryker Sustainability Solutions20222—
+8K212271smart-syncNorthh Medical GmbH20220—
+8K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+8K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+8K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+8K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+8K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+8K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+8K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+8K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+8K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+8K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+8K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20172—
+8K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+8K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+8K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+8K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd.20147—
+8K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+8K132033BM3/BM3 PlusNoblitt & Rueland20130—
+8K131763Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd.20130—
+8K130056Patient MonitorLd Technology, LLC20130—
+8K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+8K120631Patient MonitorAdvanced Instruments, Inc.20120—
+8K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+8K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+8K112803Patient MonitorGuangdong Biolight Meditech Co., Ltd.20110—
+8K110723M-LNCS Oximetry Sensors, Reprocessed M-LNCS Oximetry SensorsMasimo Corporation20110—
+8K101031Masimo Disposable Oximetry Ear Sensor, Model E1Masimo Corporation20105—
+8K101896Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation201062—
+8K102040Patient MonitorGuangdong Biolight Meditech Co., Ltd.20101—
+8K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+8K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation201039—
+8K094046LNCS Oximetry Sensors, Reprocessed LNCS Oximetry SensorsMasimo Corporation20100—
+8K090662Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ DbipMasimo Corporation200911
+9K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+9K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+9K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+9K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+9K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+9K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+9K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+9K241397HinscopeHinlab Sas20240—
+9K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+9K232111NeoBeat, NeoBeat MiniLaerdal Medical AS20240—
+9K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+9K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+9K222330The Heart SeatCasana Care, Inc.20230—
+9K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+9K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+9K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+9K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+9K222550Current Health SystemCurrent Health, Ltd.20221—
+9K212975MedWandMedwand Solutions, Inc.20221—
+9K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+9K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+9K192595ExSpiron 2XiRespiratory Motion20190—
+9K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+9K191018Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive SensorsSurgical Instrument Service and Savings, Inc.20190—
+9K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+9K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+9K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+9K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+9K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+9K140430740 SelectCas Medical Systems, Inc.20141—
+9K121912E1 Ear SensorsMasimo Corporation20124—
+9K113596Masimo Set Reusable Oximetry SensorsMasimo Corporation20120—
+9K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation201138—
+9K111888Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation201159—
+10K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+10K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+10K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+10K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+10K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+10K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+10K232915EpiMonitorEmpatica S.r.l.20241—
+10K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+10K231506Current Health SystemCurrent Health, Ltd.20230—
+10K230415Cadwell GuardianCadwell Industries, Inc.20230—
+10K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+10K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—