510(k) Report

Devices descending from K971910

472 later devices reach Multi-Parameter Module (M3000A)/Display Unit (M3046A) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+7K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+7K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd.20147—
+7K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+7K132033BM3/BM3 PlusNoblitt & Rueland20130—
+7K131763Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd.20130—
+7K130056Patient MonitorLd Technology, LLC20130—
+7K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+7K120631Patient MonitorAdvanced Instruments, Inc.20120—
+7K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+7K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+7K112803Patient MonitorGuangdong Biolight Meditech Co., Ltd.20110—
+7K110723M-LNCS Oximetry Sensors, Reprocessed M-LNCS Oximetry SensorsMasimo Corporation20110—
+7K101031Masimo Disposable Oximetry Ear Sensor, Model E1Masimo Corporation20105—
+7K101896Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation201062—
+7K102040Patient MonitorGuangdong Biolight Meditech Co., Ltd.20101—
+7K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+7K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation201039—
+7K094046LNCS Oximetry Sensors, Reprocessed LNCS Oximetry SensorsMasimo Corporation20100—
+7K090662Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ DbipMasimo Corporation200911
+8K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+8K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+8K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+8K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+8K232111NeoBeat, NeoBeat MiniLaerdal Medical AS20240—
+8K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+8K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+8K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+8K232915EpiMonitorEmpatica S.r.l.20241—
+8K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+8K231506Current Health SystemCurrent Health, Ltd.20230—
+8K222330The Heart SeatCasana Care, Inc.20230—
+8K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+8K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+8K212975MedWandMedwand Solutions, Inc.20221—
+8K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+8K191018Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive SensorsSurgical Instrument Service and Savings, Inc.20190—
+8K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+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—
+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—
+9K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+9K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+9K252981EmbraceMiniEmpatica S.r.l.20251—
+9K250515EpiMonitorEmpatica S.r.l.20250—
+9K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+9K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+9K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+9K230415Cadwell GuardianCadwell Industries, Inc.20230—
+9K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+9K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+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—
+9K150620740 SelectCas Medical Systems, Inc.201501
+9K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale20133—
+10K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+10K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+10K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+10K213515WesperO2Wesper, Inc.20220—
+10K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+11K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+11K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+12K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—