510(k) Report

Devices descending from K973887

1,000 later devices reach Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+10K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+10K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+10K250515EpiMonitorEmpatica S.r.l.20250—
+10K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+10K243837iBSMIorbit Digital Technologies Private Limited20250—
+10K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+10K242842ANNE View, Central HubSibel Health, Inc.20251—
+10K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+10K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+10K240251ANNE ChestSibel Health, Inc.20240—
+10K240305ANNE LimbSibel Health, Inc.20240—
+10K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+10K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+10K230415Cadwell GuardianCadwell Industries, Inc.20230—
+10K223578T3 Platform softwareEtiometry, Inc.20232—
+10K223498Radius VSM and AccessoriesMasimo Corporation202312
+10K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+10K213423T3 Platform softwareEtiometry, Inc.20232—
+10K222463EchoGo Heart FailureUltromics Limited20227—
+10K223246Hillrom Heart and Respiration Rate Monitoring System powered by EarlySenseBaxter Healthcare Corproration20220—
+10K214072Masimo O3 Regional Oximeter SystemMasimo Corporation20221—
+10K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+10K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+10K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+10K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+10K212227Philips MR Patient Care PortalInvivo Corporation202101
+10K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+10K201306Hamilton-C3Hamilton Medical AG20210Class I
+10K201658Hamilton-C6Hamilton Medical AG20201Class I
+10K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+10K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+10K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D…Vitalconnect, Inc.20201—
+10K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+10K192595ExSpiron 2XiRespiratory Motion20190—
+10K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+10K180295Hamilton-G5Hamiton Medical AG20192—
+10K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+10K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+10K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+10K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+10K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.201741
+10K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+10K153688Edi Catheter ENFitMaquet Critical Care AB201711
+10K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+10K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB20154—
+10K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+10K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+10K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+10K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+10K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+10K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+10K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+10K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+10K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.20124Class I
+10K103211Avea VentilatorCare Fusion20115Class I
+11K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+11K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+11K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+11K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+11K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+11K251293CardioVisionIcardio.Ai20250—
+11K243324Masimo O3 Regional OximeterMasimo Corporation20250—
+11K250757Radius VSM and AccessoriesMasimo Corporation20250—
+11K241479Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc.20251—
+11K240860EchoGo Amyloidosis (1.0)Ultromics Limited20242—
+11K240013EchoGo Heart Failure (2.0)Ultromics Limited20240—
+11K231531Pediarity™Hinlab, Inc.20230—
+11K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+11K223905Vivio® LVEDP SystemAvicena, LLC20230—
+11K231335Cleerly ISCHEMIACleerly, Inc.20230—
+11K231276SmartCardia 7L PlatformSmartcardia SA20230—
+11K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+11K212271smart-syncNorthh Medical GmbH20220—
+11K210384Carescape R860Datex-Ohmeda, Inc.20210—
+11K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—
+11K193228Hamilton-G5Hamilton Medical AG20201—
+11K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB20193—
+11K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+11K170872Aisys CS2Datex-Ohmeda, Inc.201704
+11K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+11K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+11K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+11K122438Hamilton-MR1Hamilton Medical AG201311
+11K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+12K254066Etiometry PlatformEtiometry, Inc.20260—
+12K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K250151Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai20250—
+12K243866InVision Precision Cardiac AmyloidInVision Medical Technology Corporation20250—
+12K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+12K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+12K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…Maquet Critical Care AB20210Class I
+12K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB20200Class I
+12K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+12K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+12K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+13K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I
+13K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+13K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+14K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—