510(k) Report

Devices descending from K972502

149 later devices reach Spacelabs Medical Integrated Multiparameter Module 90496 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+6K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+6K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+6K132037Vital Signs MonitorMindray North America201432
+6K132038Accutorr 7 Vital Signs MonitorMindray North America20142—
+6K113183PMS8210A (Iris) Multi-Parameter Patient Monitor, Model Code 500Shanghai 3f Electronics Co, Ltd.20120—
+6K103686STAR 50 NLarsen & Toubro Limited20111—
+6K090172Star 55 Model 100Larsen & Toubro Limited20090—
+6K082685Galaxy 55Larsen & Toubro Limited20080—
+7K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+7K253436c-med0 alphaCosinuss GmbH20260—
+7K231625VitalDetectWellvii, Inc.20240—
+7K230415Cadwell GuardianCadwell Industries, Inc.20230—
+7K221113Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+7K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+7K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+7K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+7K202892Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc.202111
+7K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+7K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+7K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+7K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+7K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+7K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+7K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+7K170712Accutorr 7/VS-900 Vital Signs MonitorShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201711
+7K132033BM3/BM3 PlusNoblitt & Rueland20130—
+8K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+8K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+8K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+8K233038Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc.202401
+8K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+8K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+8K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+8K222330The Heart SeatCasana Care, Inc.20230—
+8K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+8K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+8K212975MedWandMedwand Solutions, Inc.20221—
+8K213515WesperO2Wesper, Inc.20220—
+8K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+8K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+8K182821Accutorr 7/VS-900/VS-900c Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.201901
+9K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+9K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+9K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+9K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+9K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+10K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+10K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—