510(k) Report

Devices descending from K964239

42 later devices reach Combination Oximeter/Carbon Dioxide Gas Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031741Medley ETCO2 Module (Includes Accessories), Model 8300Alaris Medical Systems, Inc.200402
+1K024300Microcap Plus/NPB-75Oridion Medical 1987, Ltd.200320—
+1K982969Nonin Pulse Oximeter and Carbon Dioxide Detector, Models 9843, 9845 and 9847Nonin Medical, Inc.19990—
+1K983635Julian Anesthesia Workstation, Model # JulianDraeger Medical, Inc.199911—
+1K980325Microstream Nasal Cannula FilterlineOridion Medical, Ltd.199823
+1K980324Microstream Fillerline or/EmsOridion Medical, Ltd.199817
+1K980327Microstream Filterline IcuOridion Medical, Ltd.199827
+2K181467Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance…Oridion Medical 1987, Ltd.2019011
+2K143127CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only styleDispo-Med (Malaysia) Sdn Bhd20150—
+2K133886Perseus A500Draeger Medical GmbH20142Class I
+2K121927Microstream Filterline IcuOridion Medical 1987, Ltd.20120—
+2K083056Neo-Stat CO2 <KGMercury Medical20091—
+2K063752Lifesense, Model LS1-9RNonin Medical, Inc.200712—
+2K042607Primus USDraeger Medical, Inc.2004102
+2K040246Fukuda Denshi Dynascope Model DS-7141 Portable Patient MonitorFukuda Denshi USA, Inc.20044—
+2K012391Mac-Line CO2 Nasal Cannula Sample LineOridion Medical 1987, Ltd.200103
+3K230931AtlanDrägerwerk AG Co. Kgaa20231Class I
+3K182362MaxCap Ped and MaxCap NeoMaxtec, LLC20190—
+3K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+3K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+3K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+3K093853Single-Patient Use Disposable Sensor SeriesNonin Medical, Inc.20102—
+3K093306Single-Patient Use Disposable SensorNonin Medical, Inc.20100—
+3K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc.20097—
+3K081891Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc.20083—
+4K252746Atlan (A100); Atlan (A100 XL); Atlan (A350); Atlan (A350 XL)Drägerwerk AG Co. Kgaa20260—
+4K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+4K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+4K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+4K103685Pulse Oximeter Sensor (Disposable and Reusable) Model RSA002DN, RSJ002DA, RSJ091DI…Beijing Rongrui-Century Scie. & Tech. Co., Ltd.20110—
+4K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited20110—
+4K083697Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…Fukuda Denshi USA, Inc.20092—
+5K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+5K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+5K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+5K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+5K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+5K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+5K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+5K134046Fukuda Denshi Dynascope Model DS-8100N/8100M Patient MonitorFukuda Denshi USA, Inc.201502
+6K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+6K233827OxiWearOxiwear, Inc.20240—