510(k) Report

Devices descending from K964122

456 later devices reach HP Star ST and Arrhhythmia Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K121912E1 Ear SensorsMasimo Corporation20124—
+9K113596Masimo Set Reusable Oximetry SensorsMasimo Corporation20120—
+9K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation201138—
+9K111888Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation201159—
+10K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+10K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+10K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+10K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+10K232915EpiMonitorEmpatica S.r.l.20241—
+10K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+10K231506Current Health SystemCurrent Health, Ltd.20230—
+10K230415Cadwell GuardianCadwell Industries, Inc.20230—
+10K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+10K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+10K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+10K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+10K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+10K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+10K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+10K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.20175—
+10K150620740 SelectCas Medical Systems, Inc.201501
+10K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.201514—
+10K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale20133—
+11K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+11K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+11K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd.20260—
+11K252981EmbraceMiniEmpatica S.r.l.20251—
+11K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+11K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…Unimed Medical Supplies, Inc.20250—
+11K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…Unimed Medical Supplies, Inc.20250—
+11K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…Unimed Medical Supplies, Inc.20250—
+11K250515EpiMonitorEmpatica S.r.l.20250—
+11K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+11K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+11K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc.20251—
+11K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+11K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+11K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+11K213515WesperO2Wesper, Inc.20220—
+11K202851Spo2 SensorJkh USA, LLC20201—
+11K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+11K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+11K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+11K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+11K173368Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd.20180—
+11K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+11K173045OximeterShenzhen Greatmade Tech Limited20180—
+11K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+12K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+12K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+12K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+12K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+12K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20200—
+12K192608Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd20200—
+12K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+13K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—