510(k) Report

Devices descending from K855127

64 later devices reach Ambulatory Blood Pressure Monitor Spacelabs #90202 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103732Spacelabs Model 90217A Ambulatory Blood Pressure (Abp) MonitorSpacelabs Healthcare, Ltd.201111
+1K060315Healthstats Bpro Ambulatory Blood Pressure Monitoring SystemHealthstats International Pte., Ltd.200619—
+1K041169Piesometer, Model MK-1Canamet Canadian Natl Medical Technologies, Inc.20040—
+1K031479Ambulatory Blood Pressure (Abp) 92506 Report Management System (RMS), Model 92506Datex-Ohmeda, Inc.200321—
+1K983996Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc.199926—
+1K964235Abpm Mobil-O-Graph Blood Pressure Monitor, Model Abp ControlIndustrielle Entwicklung Medizintechnik Und Vertri199914—
+2K173028BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC SoftwareHealthstats International Pte., Ltd.201813—
+2K141113Spacelbs Model on Trak (90227) Ambulatory Bloody Pressure (Abp) Non-InvasiveSpacelabs Healthcare, Ltd.20140—
+2K131916Bprosoft Casp PC SoftwareHealthstats International Pte., Ltd.20140—
+2K121480Ariatele Telemetry Transmitter (96281)Spacelabs Healthcare201202
+2K101002A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200Healthstats International Pte., Ltd.20102—
+2K081800T12S Telemetry TransmitterMortara Instrument, Inc.200831
+2K080192Hypervisor VI Central Monitoring System (Including TMS)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2008202
+2K072446Mobil-O-Graph NG 24 H Abp-ControlI.E.M. GmbH20079—
+2K072593A-Plus Arterial Pulse Waveform Analysis System and PC SoftwareHealthstats International Pte., Ltd.20074—
+2K021517Abp for WindowsRozinn Electronics, Inc.20020—
+2K021029ABP-2000 G-3Biotrac, Inc.20020—
+2K012647Tonoport VPar Medizintechnik GmbH20012—
+3K190792BB-613WPBiobeat Technologies, Ltd.201912—
+3K170966Tonoport VIPar Medizintechnik GmbH & Co. KG20170—
+3K140852Vectraplex CMSVectracor, Inc.20150—
+3K141020Surveyor S4 Mobile MonitorMortara Instrument, Inc.20142—
+3K142601Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co.201411
+3K132036Hypervisor Central Monitoring System (Including Telemetry Monitoring System, TMS-6016)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201417—
+3K131788Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management Application…Healthstats International Pte., Ltd.20140—
+3K121266CardioscopePulsecor Limited20120—
+3K110603Hypertension Management Software Claient Server (HMS-CS)I.E.M. GmbH20118—
+4K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+4K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+4K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+4K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+4K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+4K182297Surveyor S2Mortara Instrument, Inc.20190—
+4K161056Telemetry TransmitterEdan Instruments, Inc.201702
+4K160685Surveyor S4 Mobile MonitorMortara Instrument, Inc.201601
+4K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+4K150632Hypervisor IX Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2015142
+4K140928ABPM7100I.E.M. GmbH20145—
+5K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+5K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+5K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+5K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+5K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+5K162607BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2017121
+5K153557ABPM 7100, Hypertension Management SoftwareI.E.M. GmbH20160—
+5K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+5K151520Oscar 2Suntech Medical, Inc.201632
+6K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+6K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd.20260—
+6K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+6K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09Edan Instruments, Inc.20211—
+6K183238BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201911—
+7K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+7K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+8K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+8K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+8K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+8K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+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
+10K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+10K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—