510(k) Report

Devices descending from K980714

74 later devices reach Bci 3401 Handheld Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020350Bci 3180 Pulse OximeterBci, Inc.200202
+1K0131713420 Digit Pulse Oximeter, Model 3420Bci, Inc.200243—
+1K9914103402 Handheld Pulse OximeterBci Intl., Inc.199928—
+2K083557Bci WW1030 Pulse OximeterSmiths Medical Pm, Inc.20090—
+2K083787Bci WW1000 Pulse Oximeter, Model WW1000Smiths Medical Pm, Inc.20090—
+2K083705Bci WW1020 Pulse Oximeter, Model WW1020Smiths Medical Pm, Inc.200925—
+2K043528SpirotelMir Medical Intl. Research Srl200542—
+3K130784SpirotelMir Medical Intl. Research Srl20130—
+3K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited20110—
+3K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc.201022—
+3K093080Metaphor Metabolic MonitorTreymed, Inc.20100—
+3K061712Spirobank IIMir Medical Intl. Research Srl200640—
+4K173368Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd.20180—
+4K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.20175—
+4K152390Medke Oximetry Finger SensorShenzhen Medke Technology Co., Ltd.20160—
+4K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.201514—
+4K103530SpirodocMedical International Research USA, Inc.20114—
+4K081033MiroxiMir Medical Intl. Research Srl20090—
+4K072979Spirobank GMir Medical Intl. Research Srl200733—
+5K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd.20260—
+5K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+5K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…Unimed Medical Supplies, Inc.20250—
+5K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…Unimed Medical Supplies, Inc.20250—
+5K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…Unimed Medical Supplies, Inc.20250—
+5K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc.20251—
+5K231416Air Next (NVD-02)Nuvoair AB20240—
+5K230501Spirobank OxiMir Medical International Research USA20230—
+5K202851Spo2 SensorJkh USA, LLC20201—
+5K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+5K201002Safey Pocket SpirometerSafey Medical Devices Pvt, Ltd.20200—
+5K183089Air NextNuvoair AB20201—
+5K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+5K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+5K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+5K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+5K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+5K173045OximeterShenzhen Greatmade Tech Limited20180—
+5K170798Dictum HealthDictum Health, Inc.20175—
+5K163249GoSpiroMonitored Therapeutics, Inc.20172—
+5K141546Vitalograph Model 7000 SpirotracVitalograph (Ireland), Ltd.20142—
+5K083879Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…Innovision A/S20092—
+6K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+6K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+6K241397HinscopeHinlab Sas20240—
+6K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+6K222525Alveoair Digital SpirometerRoundworks Technologies Private Limited20230—
+6K213754SpiroHome Personal, SpiroHome ClinicInofab Saglik Teknolojileri A.S20230—
+6K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+6K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+6K222550Current Health SystemCurrent Health, Ltd.20221—
+6K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+6K202837GoSpiroMonitored Therapeutics, Inc.20200—
+6K201562SpirotracVitalograph Ireland, Ltd.20200—
+6K190561NICU V'02Cosmed Nordic Aps20200—
+6K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20200—
+6K192608Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd20200—
+6K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+6K142642Vitalograph Model 6600 CompactVitalograph (Ireland), Ltd.20150—
+6K102047Lci Option for InnocorInnovision A/S201101
+7K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+7K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+7K232915EpiMonitorEmpatica S.r.l.20241—
+7K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+7K231506Current Health SystemCurrent Health, Ltd.20230—
+7K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+8K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+8K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+8K252981EmbraceMiniEmpatica S.r.l.20251—
+8K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+8K250515EpiMonitorEmpatica S.r.l.20250—
+8K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+8K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+8K240901StethophoneSparrow Acoustics, Inc.20241—
+9K252595Stethophone ProSparrow Acoustics, Inc.20250—