510(k) Report

Devices descending from K024300

20 later devices reach Microcap Plus/NPB-75 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083056Neo-Stat CO2 <KGMercury Medical20091—
+1K063752Lifesense, Model LS1-9RNonin Medical, Inc.200712—
+1K040246Fukuda Denshi Dynascope Model DS-7141 Portable Patient MonitorFukuda Denshi USA, Inc.20044—
+2K182362MaxCap Ped and MaxCap NeoMaxtec, LLC20190—
+2K093853Single-Patient Use Disposable Sensor SeriesNonin Medical, Inc.20102—
+2K093306Single-Patient Use Disposable SensorNonin Medical, Inc.20100—
+2K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc.20097—
+2K081891Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc.20083—
+3K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+3K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+3K103685Pulse Oximeter Sensor (Disposable and Reusable) Model RSA002DN, RSJ002DA, RSJ091DI…Beijing Rongrui-Century Scie. & Tech. Co., Ltd.20110—
+3K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited20110—
+3K083697Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…Fukuda Denshi USA, Inc.20092—
+4K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+4K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+4K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+4K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+4K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+4K134046Fukuda Denshi Dynascope Model DS-8100N/8100M Patient MonitorFukuda Denshi USA, Inc.201502
+5K233827OxiWearOxiwear, Inc.20240—