510(k) Report

Devices descending from K042601

15 later devices reach Capnostat 5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192446CO2 Mainstream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20201—
+1K171828ETCO2 SensorOrantech, Inc.20180—
+1K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+1K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+1K123797NT1D Vital Signs MonitorNew Tech, Inc.20130—
+1K100941Infinity Mcable - Mainstream CO2Draeger Medical AG & Co. KG20101—
+1K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+1K062095Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.20063—
+2K221118CO2 Mainstream SensorDraegerwerk AG & CO Kgaa20230—
+2K210019Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+Unimed Medical Supplies, Inc.20210—
+2K112190Patient MonitorMediana Co., Ltd.20110—
+2K110922Patient MonitorEdan Instruments, Inc.201111
+2K100217Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd.20101—
+2K082045Modification to Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.200801
+3K120631Patient MonitorAdvanced Instruments, Inc.20120—