510(k) Report

Devices descending from K083821

39 later devices reach Vital Signs Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120173Patient MonitorEdan Instruments, Inc.201210—
+1K113653Patient MonitorEdan Instruments, Inc.201212
+1K113623Patient MonitorEdan Instruments, Inc.2012152
+1K110922Patient MonitorEdan Instruments, Inc.201111
+1K093016Vital Signs MonitorShenzhen Creative Industry Co., Ltd.201016—
+2K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+2K170820Capnograph and OximeterCmi Health, Inc.20181—
+2K160981Patient MonitorEdan Instruments, Inc.201681
+2K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+2K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+2K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+2K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+2K120631Patient MonitorAdvanced Instruments, Inc.20120—
+3K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+3K192488CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20200—
+3K192514Patient MonitorEdan Instruments, Inc.202061
+3K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+3K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+3K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+3K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+3K161056Telemetry TransmitterEdan Instruments, Inc.201702
+3K152552Patient MonitorEdan Instruments, Inc.201621
+4K253436c-med0 alphaCosinuss GmbH20260—
+4K231625VitalDetectWellvii, Inc.20240—
+4K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+4K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+4K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+4K202336Patient MonitorEdan Instruments, Inc.202131
+4K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+5K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+5K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+5K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+5K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+5K222330The Heart SeatCasana Care, Inc.20230—
+5K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+5K212975MedWandMedwand Solutions, Inc.20221—
+5K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+6K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+6K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—