510(k) Report

Devices descending from K051352

28 later devices reach Oximax NPB-40 Handheld Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171241Pulse OximeterHunan Accurate Bio-Medical Technology Co., Ltd.20180—
+1K141542Nellcor Portable SPO2 Patient Monitoring System ( Npspms )Covidien, LLC20140—
+1K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+1K083079Quanta Pulse Oximeter, Model: Pulse Link 1000 or QH100Quanta Computer, Inc.20090—
+1K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+2K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+2K092727H100B Pulse OximeterEdan Instruments, Inc.20090—
+2K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+2K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+2K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+3K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+3K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+3K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+3K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+3K130056Patient MonitorLd Technology, LLC20130—
+3K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+3K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+4K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+4K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+4K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+5K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+5K230415Cadwell GuardianCadwell Industries, Inc.20230—
+5K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+5K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+5K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+6K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+6K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302