510(k) Report

Devices descending from K032971

57 later devices reach Tidal Wave SP Model 710/715 and 715 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123797NT1D Vital Signs MonitorNew Tech, Inc.20130—
+1K092611Sonarmed Airway Monitoring System, Model 0901Sonarmed, Inc.20102—
+1K083821Vital Signs MonitorEdan Instruments, Inc.200939—
+1K042601Capnostat 5Respironics Novametrix, Inc.2004151
+2K192446CO2 Mainstream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20201—
+2K171828ETCO2 SensorOrantech, Inc.20180—
+2K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+2K143042SonarMed AirWave, Airway Monitoring SystemSonarmed, Inc.201611
+2K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+2K120173Patient MonitorEdan Instruments, Inc.201210—
+2K113653Patient MonitorEdan Instruments, Inc.201212
+2K113623Patient MonitorEdan Instruments, Inc.2012152
+2K110922Patient MonitorEdan Instruments, Inc.201111
+2K100941Infinity Mcable - Mainstream CO2Draeger Medical AG & Co. KG20101—
+2K093016Vital Signs MonitorShenzhen Creative Industry Co., Ltd.201016—
+2K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+2K062095Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.20063—
+3K221118CO2 Mainstream SensorDraegerwerk AG & CO Kgaa20230—
+3K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+3K210019Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+Unimed Medical Supplies, Inc.20210—
+3K193058SonarMed AirWave Airway Monitoring SystemSonarmed, Inc.20200Class I
+3K170820Capnograph and OximeterCmi Health, Inc.20181—
+3K160981Patient MonitorEdan Instruments, Inc.201681
+3K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+3K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+3K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+3K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+3K120631Patient MonitorAdvanced Instruments, Inc.20120—
+3K112190Patient MonitorMediana Co., Ltd.20110—
+3K100217Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd.20101—
+3K082045Modification to Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.200801
+4K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+4K192488CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20200—
+4K192514Patient MonitorEdan Instruments, Inc.202061
+4K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+4K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+4K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+4K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+4K161056Telemetry TransmitterEdan Instruments, Inc.201702
+4K152552Patient MonitorEdan Instruments, Inc.201621
+5K253436c-med0 alphaCosinuss GmbH20260—
+5K231625VitalDetectWellvii, Inc.20240—
+5K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+5K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+5K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+5K202336Patient MonitorEdan Instruments, Inc.202131
+5K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+6K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+6K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+6K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+6K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+6K222330The Heart SeatCasana Care, Inc.20230—
+6K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+6K212975MedWandMedwand Solutions, Inc.20221—
+6K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+7K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+7K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—