510(k) Report

Devices descending from K003004

146 later devices reach Oscar 2, Model 222 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151520Oscar 2Suntech Medical, Inc.201632
+1K092785Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software…Vasomedical, Inc.20103—
+1K051368BR 102 Plus Blood Pressure Holter SystemSchiller AG20050—
+1K042109Diasys Integra IINovacor France20050—
+1K020440NewcorSiemens Medical Systems, Inc.2002910
+1K021029ABP-2000 G-3Biotrac, Inc.20020—
+1K013319Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) MonitorNonin Medical, Inc.2002124—
+2K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd.20260—
+2K231104ABPMproSomnomedics GmbH20230—
+2K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09Edan Instruments, Inc.20211—
+2K131812Sensis, Sensis LiteSiemens Medi Cal Solutions, Inc.20132—
+2K111096Vasomedical-Biox Combined 12 Channel Ambulatory Ecg and Blood Pressure Recorder Model…Vasomedical, Inc.20111—
+2K101571Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp201058
+2K041156Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc.2004891
+2K031487Model Avant 2120 Pulse Oximeter and NibpNonin Medical, Inc.200442—
+3K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+3K230184Holter ECG and ABP SystemEdan Instruments, Inc.20230—
+3K181311Philips Hemodynamic Application R1.0Philips Medical Systems Nederlands B.V.201802
+3K150493SensisSiemens Medi Cal Solutions, Inc.2015111
+3K131497Mckesson Cardiology HemoMckesson Israel, Ltd.2013310
+3K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc.20097—
+3K053209Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement SystemSuntech Medical, Inc.200613—
+3K052669Avant Digital Pulse Oximetry System, Model 4000, 4100Nonin Medical, Inc.200511—
+3K0433594100 Patient Oximeter ModuleNonin Medical, Inc.200575—
+3K043162PMP4 Oxy ProCard Guard Scientific Survival, Ltd.20040—
+3K040589Modification to Avant 9600 Pulse OximeterNonin Medical, Inc.200427—
+4K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV20250—
+4K223812Sensis Vibe (VD15)Siemens Medical Solutions USA, Inc.202303
+4K230881Change Healthcare Cardiology Hemodynamics™Change Healthcare Israel, Ltd.202302
+4K191574OxSAT 100S.L.P., Ltd.20200—
+4K182822Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20196—
+4K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+4K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+4K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPFysicon BV20171—
+4K162580Guardian Angel GA1000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20172—
+4K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+4K122401Tango M2 Blood Pressure MonitorSuntech Medical, Inc.20120—
+4K120052CvinsightIntelomed, Inc.20120—
+4K120465Earlysense (Everon) SystemEarlysense, Ltd.20129—
+4K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp.200914—
+4K082113Nox T3, Noxturnal (PC Application)Nox Medical2008171
+4K081285Finger Pulse Oximeter, Model 9560Nonin Medical, Inc.200840—
+4K071642Mediaid M960 Series, Vital Signs Monitor and Mediaid M900 Series, Pulse OximeterMediaid, Inc.20080—
+4K063814BP-200 PlusSchiller AG20077—
+4K060820Cycle BP Monitor and Pulse Oximeter, Model 1060Suntech Medical, Inc.20062—
+5K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+5K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+5K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+5K242290DormoTech NLabDormotech Medical, Ltd.20250—
+5K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+5K222597BabySat 3Owlet Babycare, Inc.20230—
+5K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+5K200537OxxiomTrue Wearables, Inc.20200—
+5K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+5K191207Guardian Angel Rx GA2001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+5K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+5K152043Diagnostic Station DS20Schiller AG20161—
+5K152831Spot SkanSkanray Technologies Private Limited20160—
+5K151512Star 60Skanray Technologies Private Limited20160—
+5K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+5K143272ApneaLink AirResmed Germany, Inc.20157—
+5K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd.20146—
+5K131379EarlysenseEarlysense, Ltd.20137—
+5K131021Pulse OximeterNonin Medical, Inc.20133—
+5K124062QDC-Pro, and Nox-RipNox Medical20133—
+5K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…Inovise Medical, Inc.20123—
+5K121617SensicardiacDiacoustic Medical (Pty)201210—
+5K113865PultolSharp Corporation20120—
+5K110704SENSIDiacoustic Medical Devices (Pty), Ltd.201113—
+5K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+5K092620MD300C318 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.200910—
+6K233827OxiWearOxiwear, Inc.20240—
+6K223721Masimo StorkMasimo Corporation20230—
+6K191403Pulse OximeterNonin Medical, Inc.20191—
+6K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co., Ltd.20190—
+6K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+6K171836EarlySense Bed Sensing UnitEarlysense, Ltd.20180—
+6K172986Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO20172—
+6K170182Cardiovit FT-1Schiller AG20170—
+6K163665MATRx plusZephyr Sleep Technologies20173—
+6K152911EarlySense Insight SytemEarlysense, Ltd.20165—
+6K151361Nox RIP Belts & CablesNox Medical Ehf20152—
+6K142888Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20158—
+6K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+6K140785Pulse OximeterNonin Medical, Inc.20140—
+6K131883Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc.20141—
+6K130660Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc.20130—
+6K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd.20139—
+6K131287CardiosleeveRijuven Corp20131—
+6K111494Handheld Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20120—
+7K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbH20260—
+7K253274BedDot (G1)Intelligent Dots, LLC20260—
+7K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+7K242447Falcon HSTCompumedics Limited20250—
+7K214115MightySat -OTCMasimo Corporation20241—
+7K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+7K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+7K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102…Shenzhen Narig Bio-Medical Technology Co., Ltd.20221—
+7K202743Med-Link Temp-pulse OximeterShenzhen Med-Link Electronics Tech Co., Ltd.20210—
+7K201299HD StethHd Medical, Inc.20200—