510(k) Report

Devices descending from K923343

463 later devices reach Hewlett-Packard Model M1020A Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+9K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+9K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+9K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+9K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+9K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+9K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+9K232111NeoBeat, NeoBeat MiniLaerdal Medical AS20240—
+9K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+9K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+9K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+9K232915EpiMonitorEmpatica S.r.l.20241—
+9K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+9K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+9K230842SignalHF (IM008)Implicity, Inc.20230—
+9K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+9K231506Current Health SystemCurrent Health, Ltd.20230—
+9K222330The Heart SeatCasana Care, Inc.20230—
+9K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+9K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+9K212975MedWandMedwand Solutions, Inc.20221—
+9K221203AHI SystemFifth Eye, Inc.20220—
+9K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+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—
+10K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+10K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+10K252981EmbraceMiniEmpatica S.r.l.20251—
+10K250515EpiMonitorEmpatica S.r.l.20250—
+10K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+10K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+10K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+10K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+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—
+10K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+10K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+10K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+10K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+10K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+10K150620740 SelectCas Medical Systems, Inc.201501
+10K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale20133—
+11K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+11K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+11K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+11K213515WesperO2Wesper, Inc.20220—
+11K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+12K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+12K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+13K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—