510(k) Report

Devices descending from K915699

60 later devices reach Nellcor Portable Pulse Oximeter Model N-20 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981655Spacelabs Medical Disposable SP02 SensorSpacelabs Medical, Inc.19990—
+1K963707Nellcor Puritan Bennett NPB-40 Handheld Pulse (NPB-40)Nellcor Puritan Bennett, Inc.199658—
+2K100225Pulse Oximeter Model P10Mediana Co., Ltd.20113—
+2K070193Envitec Oxipen Pulse Oximeter and AccessoriesEnvitec-Wismar GmbH200715—
+2K051352Oximax NPB-40 Handheld Pulse OximeterNellcor Puritan Bennett, Inc.200528—
+2K972468NPB-195 Pulse OximeterNellcor Puritan Bennett, Inc.19976—
+2K971946NPB-190 Pulse Oximeter (NPB-190)Nellcor Puritan Bennett, Inc.19971—
+3K171241Pulse OximeterHunan Accurate Bio-Medical Technology Co., Ltd.20180—
+3K152659V10Mediana Co., Ltd.20162—
+3K141542Nellcor Portable SPO2 Patient Monitoring System ( Npspms )Covidien, LLC20140—
+3K133064Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip Large R-3211-31, Finger…Envitec-Wismar GmbH20140—
+3K113165Mini-MedicAthena Gtx201213—
+3K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+3K083079Quanta Pulse Oximeter, Model: Pulse Link 1000 or QH100Quanta Computer, Inc.20090—
+3K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+3K052544Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc.20060—
+3K041548Sentec Digital Monitor Model #SDMSentec, Inc.200459
+4K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG20240—
+4K190792BB-613WPBiobeat Technologies, Ltd.201912—
+4K170497V10Mediana Co., Ltd.201711
+4K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+4K092727H100B Pulse OximeterEdan Instruments, Inc.20090—
+4K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+4K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+4K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+4K071672Sentec Digital Monitoring SystemSentec AG200741
+5K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+5K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+5K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+5K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+5K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+5K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+5K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+5K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+5K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+5K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+5K130056Patient MonitorLd Technology, LLC20130—
+5K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+5K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG2010312
+5K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+6K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+6K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+6K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+6K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+6K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+6K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+6K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+6K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+6K162014Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2…Bluepoint Medical GmbH & Co. KG20170—
+6K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…Sentec AG201519
+7K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+7K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+7K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+7K230415Cadwell GuardianCadwell Industries, Inc.20230—
+7K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+7K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+7K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+8K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+8K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+9K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302