510(k) Report

Devices descending from K963327

75 later devices reach Tidal Wave Carbon Dioxide Monitor, Model 610 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072813Emma Analyzer (Kpa & MMHG); Emma Monitor (Kpa & MMHG)Phasein AB20071—
+1K063167Emma Analyzer (Kpa) and (MMHG); Emma Monitor (Kpa) and (MMHG)Phasein AB20072—
+1K051857Veo Multigas Monitor for Pocket PC, Model 400221Weissburg Associates200516—
+1K032971Tidal Wave SP Model 710/715 and 715Respironics Novametrix, Inc.2004577
+2K201590EMMA CapnographMasimo Corporation20210—
+2K123797NT1D Vital Signs MonitorNew Tech, Inc.20130—
+2K092611Sonarmed Airway Monitoring System, Model 0901Sonarmed, Inc.20102—
+2K083821Vital Signs MonitorEdan Instruments, Inc.200939—
+2K081601Veo Multigas Monitor for Pocket PCPhasein AB200812—
+2K042601Capnostat 5Respironics Novametrix, Inc.2004151
+3K192446CO2 Mainstream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20201—
+3K171828ETCO2 SensorOrantech, Inc.20180—
+3K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+3K143042SonarMed AirWave, Airway Monitoring SystemSonarmed, Inc.201611
+3K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+3K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+3K123043Irma C02 Model 200101; Irma AX 200601Phasein AB201211—
+3K120173Patient MonitorEdan Instruments, Inc.201210—
+3K113653Patient MonitorEdan Instruments, Inc.201212
+3K113623Patient MonitorEdan Instruments, Inc.2012152
+3K110922Patient MonitorEdan Instruments, Inc.201111
+3K100941Infinity Mcable - Mainstream CO2Draeger Medical AG & Co. KG20101—
+3K093016Vital Signs MonitorShenzhen Creative Industry Co., Ltd.201016—
+3K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+3K062095Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.20063—
+4K250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.20250—
+4K221118CO2 Mainstream SensorDraegerwerk AG & CO Kgaa20230—
+4K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+4K210019Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+Unimed Medical Supplies, Inc.20210—
+4K193058SonarMed AirWave Airway Monitoring SystemSonarmed, Inc.20200Class I
+4K170820Capnograph and OximeterCmi Health, Inc.20181—
+4K160981Patient MonitorEdan Instruments, Inc.201681
+4K160481Vivo 60Breas Medical AB201672
+4K140264MADMThornhill Research, Inc.20150—
+4K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+4K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+4K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+4K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+4K120631Patient MonitorAdvanced Instruments, Inc.20120—
+4K112190Patient MonitorMediana Co., Ltd.20110—
+4K100217Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd.20101—
+4K082045Modification to Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.200801
+5K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+5K193586Vivo 45 LSBreas Medical AB20212Class I
+5K192488CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20200—
+5K192514Patient MonitorEdan Instruments, Inc.202061
+5K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+5K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+5K181166Trilogy EvoRespironics, Inc.20195Class I
+5K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+5K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+5K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+5K161056Telemetry TransmitterEdan Instruments, Inc.201702
+5K152552Patient MonitorEdan Instruments, Inc.201621
+6K253436c-med0 alphaCosinuss GmbH20260—
+6K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+6K233452Vivo 45 LSBreas Medical AB202501
+6K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+6K240807VM-2000Ventis Medical, Inc.20240—
+6K231625VitalDetectWellvii, Inc.20240—
+6K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+6K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+6K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+6K202336Patient MonitorEdan Instruments, Inc.202131
+6K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+7K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+7K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+7K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+7K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+7K222330The Heart SeatCasana Care, Inc.20230—
+7K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+7K212975MedWandMedwand Solutions, Inc.20221—
+7K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+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—