510(k) Report

Devices descending from K061822

77 later devices reach Omron Automatic Blood Pressure Monitor with Comfit Cuff, Model Hem 780 N3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131788Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management Application…Healthstats International Pte., Ltd.20140—
+1K133383HEM-7320Omron Healthcare, Inc.201417—
+1K112620Disital Blood Pressure MonitorNihon Seimitsu Sokki Co., Ltd.20120—
+1K101681Transtek Blood Pressure Monitor Model TMB-986, TMB-987, TMB-995Zhongshan Transtek Electronics Co., Ltd.201121—
+1K101242Genesis DM Model: 6053000A1Honeywell Hommed, LLC201018—
+1K092161Full Automatic (Nibp) Blood Pressure Monitor, Model HL868BFHealth & Life Co., Ltd.200914—
+1K0802891500 PROOmron Healthcare, Inc.20080—
+2K170605Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure…Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.201811—
+2K180335Accutension Smartphone Auscultatory BloodShanghai Hulu Devices Co., Ltd.20180—
+2K162092Evolv Model BP7000 Upper Arm Blood Pressure MonitorOmron Healthcare, Inc.20163—
+2K141792Genesis Touch SystemHoneywell Hommed20140—
+2K132930Myhealthpoint Telehealth ManagerEntra Health Systems20140—
+2K120325Connected Care Mobile ApplicationWatermark Medical20120—
+2K113238Full Automatic (Nibp) Blood Pressue MonitorHealth & Life Co., Ltd.20129—
+2K120058Transtek Blood Pressure MonitorZhongshan Transtek Electronics Co., Ltd.201220—
+2K112858Genesis Touch SystemHoneywell Hommed, LLC201211—
+2K103214M3810A Philips Telemonitoring System with Edevice BRIDGED130Lifeline Systems, Inc.20103—
+2K093831Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RTHealth & Life Co., Ltd.201012—
+3K253059Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)Tournicare Pty, Ltd.20260—
+3K252779YUWELL® Electronic Blood Pressure Monitor (YE630CR)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.20260—
+3K241431Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0…Joytech Healthcare Co., Ltd.20250—
+3K202372Upper Arm Electronic Blood Pressure MonitorConmo Electronic Company Limited20200—
+3K200939Electronic Blood Pressure MonitorJiangsu Yuyue Medical Equipment & Supply Co., Ltd.20206—
+3K193456Arm Blood Pressure MonitorNingbo Ranor Medical Science & Technology Co., Ltd.20201—
+3K183491Arm Blood Pressure MonitorXuzhou Yongkang Electronic Science Technology Co., Ltd.20190—
+3K142968Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20148—
+3K141706Ecare Coordinator (Ecc)Visicu, Inc.201422
+3K133252Healthinterlink BeaconHealthinterlink, LLC20143—
+3K130971Optum Telehealth ApplicationOptumhealth Care Solutions, Inc.20131—
+3K130563Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd.20133—
+3K131121Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd.20139—
+3K123780Transtek Blood Pressure MonitorZhongshan Transtek Electronics Co., Ltd.201319—
+3K122285Tablet CommanderCardiocom, LLC20125—
+3K120941Constant Care Lilah Home Health Monitoring SystemConstant Care, LLC20121—
+4K253124Upper arm electronic blood pressure monitor (XB-01)Shenzhen Ziqing Medical Equipment Co., Ltd.20260—
+4K253228YUWELL® Electronic Blood Pressure Monitor (YE650AR)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.20260—
+4K253142Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)Ningbo Ranor Medical Technology Co., Ltd.20260—
+4K251143Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)Ningbo Ranor Medical Science & Technology Co., Ltd.20250—
+4K223170Electronic Blood Pressure Monitor, model: HTD6602USHetaida Technology Co., Ltd.20231—
+4K210152Automatic Digital Blood Pressure MonitorAviche Shandong Medical Technology Co, Ltd.20210—
+4K191745Medtronic Commander FlexMedtronic Care Management Services20200—
+4K181248Comarch e-Care PlatformComarch Healthcare SA20182—
+4K180240Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20181—
+4K171406Optum TeleHealth ApplicationUnited Health Group, Inc.20170—
+4K171029eCareCoordinatorVisicu, Inc.20171—
+4K160145Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20163—
+4K153214Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20163—
+4K150311Full Automatic (NIBP)Blood Pressure MonitorHealth & Life Co., Ltd.20150—
+4K130360Constant Care Lilah Home Health Monitoring System - Multi-User VersionConstant Care, LLC20130—
+4K131395Transtek Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd.201318—
+5K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+5K243661Electronic Blood Pressure MonitorHetaida Technology Co., Ltd.20250—
+5K222398Care Team PortalVivify Health, Inc.20230—
+5K211822LifePath Remote Patient Monitoring PlatformElastic Care Incorporated20221—
+5K211127Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DMHealth & Life Co., Ltd.20210—
+5K202891Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd.202110—
+5K190507Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20192—
+5K161886Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device…Guangdong Transtek Medical Electronics Co., Ltd.20167—
+5K161156Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20160—
+6K232713Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd.20234—
+6K232621Blood pressure monitorGuangdong Transtek Medical Electronics Co., Ltd.20233—
+6K223374Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd.20230—
+6K212115Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic…Joytech Healthcare Co., Ltd.20225—
+6K200649Arm-Type Fully Automatic Digital Blood Pressure MonitorJoytech Healthcare Co., Ltd.20200—
+6K200437Blood Pressure MonitorShenzhen Jamr Technology Co., Ltd.20200—
+6K200521Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20200—
+7K253425Arm-type Fully Automatic Digital Blood Pressure Monitor…Joytech Healthcare Co., Ltd.20260—
+7K252685Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P…Joytech Healthcare Co., Ltd.20260—
+7K250548Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)Joytech Healthcare Co., Ltd.20251—
+7K241351Blood Pressure Monitor (TMB-2092-G)Guangdong Transtek Medical Electronics Co., Ltd.20240—
+7K240254Blood Pressure Monitor (TMB-2296-BT)Guangdong Transtek Medical Electronics Co., Ltd.20242—
+7K240102Blood Pressure Monitor (TMB-2287-B)Guangdong Transtek Medical Electronics Co., Ltd.20240—
+7K230566Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic…Joytech Healthcare Co., Ltd.20232—
+8K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus…JOYTECH Healthcare Co., Ltd.20260—
+8K252501Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B…Joytech Healthcare Co., Ltd.20260—
+8K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+9K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—