510(k) Report

Devices descending from K954066

67 later devices reach Miniscope MS-3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990809Cadiscope Electronic StethoscopeCaditec AG199966—
+2K100531Viscope, Model 100P,100SHd Medical Services (India) Pvt.Ltd20100—
+2K090493SignalZargis Medical Corp.20091—
+2K050097Techno-Scope Visual StethoscopeTechtrade, LLC20050—
+2K051126Cardioscope Sonoplus 3000Pulsonic Ag, Medical Technology20050—
+2K013434VP-2000/1000Colin Corp.200246—
+2K013725Meditron II Thesterthoscope SystemMeditron AS200216—
+3K222153Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)Microlife Intellectual Property GmbH20230—
+3K112521Fukuda Denshi Vasera Model VS-1500Fukuda Denshi USA, Inc.20110—
+3K112845Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20113—
+3K110704SENSIDiacoustic Medical Devices (Pty), Ltd.201113—
+3K093205PadcheckPadtest, LLC20100—
+3K082357Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office…Microlife Intellectual Property GmbH200827—
+3K080670Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical20088—
+3K050233Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model Hem-9000AIOmron Healthcare, Inc.20056—
+4K171937Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20181—
+4K151869Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland201515—
+4K131287CardiosleeveRijuven Corp20131—
+4K122129Sphygmocor XcelAtcor Medical20126—
+4K121617SensicardiacDiacoustic Medical (Pty)201210—
+4K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+4K101512Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watchbp Office Target…Microlife Intellectual Property GmbH20100—
+4K101275Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch BP Office Afib…Microlife Intellectual Property GmbH20106—
+4K081654HEM-9000AIOmron Healthcare, Inc.20080—
+4K072593A-Plus Arterial Pulse Waveform Analysis System and PC SoftwareHealthstats International Pte., Ltd.20074—
+5K253306BioTracker 2.0Biotracker, LLC20260—
+5K221742Conneqt PulseAtcor Medical20230—
+5K201299HD StethHd Medical, Inc.20200—
+5K190927Oscillometric Blood Pressure MonitorRudolf Riester GmbH20190—
+5K180155Arm Type Blood Pressure MonitorAvita Corporation20180—
+5K172431Cardiovascular AnalzyerPhysiowave, Inc.20180—
+5K170467Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20170—
+5K151520Oscar 2Suntech Medical, Inc.201632
+5K153077Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH201612—
+5K143341Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20154—
+5K131916Bprosoft Casp PC SoftwareHealthstats International Pte., Ltd.20140—
+5K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd.20139—
+5K101002A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200Healthstats International Pte., Ltd.20102—
+6K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd.20260—
+6K222979Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5WMicrolife Intellectual Property GmbH20235—
+6K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09Edan Instruments, Inc.20211—
+6K200521Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20200—
+6K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+6K190818Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20190—
+6K181988eMurmur IDCsd Labs GmbH20197—
+6K172498Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4YMicrolife Intellectual Property GmbH20173—
+6K152770ProBP 2400 Digital Blood Pressure DeviceMicrolife Intellectual Property GmbH201531
+6K131788Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management Application…Healthstats International Pte., Ltd.20140—
+6K121266CardioscopePulsecor Limited20120—
+7K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+7K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+7K232621Blood pressure monitorGuangdong Transtek Medical Electronics Co., Ltd.20233—
+7K230823AusculThing ACCAusculthing OY20230—
+7K230075Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5KMicrolife Intellectual Property GmbH20232—
+7K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+7K220766eMurmur Heart AICsd Labs GmbH20221—
+7K200297Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20202—
+8K253425Arm-type Fully Automatic Digital Blood Pressure Monitor…Joytech Healthcare Co., Ltd.20260—
+8K252685Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P…Joytech Healthcare Co., Ltd.20260—
+8K252284eMurmur Heart AICsd Labs20250—
+8K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+8K251120Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress…Microlife Corporation20251—
+8K240901StethophoneSparrow Acoustics, Inc.20241—
+8K241351Blood Pressure Monitor (TMB-2092-G)Guangdong Transtek Medical Electronics Co., Ltd.20240—
+8K202729Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20210—
+9K253982Korotkoff sound blood pressure monitorBeijing Hanvon Health Technology Co., Ltd.20260—
+9K252595Stethophone ProSparrow Acoustics, Inc.20250—