510(k) Report

Devices descending from K993637

715 later devices reach N-395 Pulse Oximeter, with Extended Device Claims through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211138Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L)…Stryker Sustainability Solutions20220—
+1K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited20110—
+1K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc.201022—
+1K092549Oxiprobe, Models BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600PBio Medical Technologies Co., Ltd.20091—
+1K061931Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models S100A-090103 and 300103…Solaris Medical Technology, Inc.20070—
+1K052544Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc.20060—
+1K033973Oxisensor II Recycled Sensor and Oximax Recycled SensorNellcor Puritan Bennett, Inc.20041—
+1K031487Model Avant 2120 Pulse Oximeter and NibpNonin Medical, Inc.200442—
+1K012706IM2001 Pulse OximeterImagyn Medical Technologies, Inc.20032—
+1K022084Atlas Monitor, Models 200,210,220Welch Allyn, Inc.2002264—
+1K012891Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables…Nellcor Puritan Bennett, Inc.20025481
+1K012451Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc.2001280—
+2K212555Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult…Covidien, LLC20220—
+2K173368Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd.20180—
+2K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc.20170—
+2K162014Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2…Bluepoint Medical GmbH & Co. KG20170—
+2K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.20175—
+2K152390Medke Oximetry Finger SensorShenzhen Medke Technology Co., Ltd.20160—
+2K152973Dyna-Vision Telemonitoring SystemTechmedic Development International B.V.20160—
+2K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+2K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.201514—
+2K132516Oxiprobe E (Oxiprobe)Bio Medical Technologies Co., Ltd.20140—
+2K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien201440—
+2K130773Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.201361
+2K123581Nellcor Oximax N-600X Pulse Oximeter, Nellcor Bedside Respiratory Patient Monitoring…Covidien, Formerly Nellcor Puritan Bennett, Inc.2013342
+2K113054EquivitalHidalgo Limited201271—
+2K111773Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant and NeonateRenu Medical, Inc.20110—
+2K101280Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeMidwest Reprocessing Center, LLC20100—
+2K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201011—
+2K100217Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd.20101—
+2K093261MOVESThornhill Research, Inc.20107Class I
+2K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc.20097—
+2K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc.20097—
+2K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO2009101
+2K083892Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc.200958—
+2K081140VisensiaObs Medical200822—
+2K073036Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc.200859—
+2K070408Duramax Reusable Oximetry SensorNellcor Puritan Bennett, Inc.20070—
+2K061993Equivital, Model EQ-01Hidalgo Limited200699—
+2K060576Nellcor Oximax N-600X Pulse OximeterNellcor Puritan Bennett, Inc.2006140—
+2K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc.20062503
+2K053112BiosignOxford Biosignals Limited20068—
+2K051271Oximax Neomax Adhesive Forehead Reflectance Oximetry SensorNellcor Puritan Bennett, Inc.20060—
+2K053209Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement SystemSuntech Medical, Inc.200613—
+2K051896Model 750E Series MonitorCas Medical Systems, Inc.200551—
+2K052186Nellcor Oximax Pulse Oximetry Sensons (Max-a, Max-AL, Max-N, Max-I, Max-PNellcor Puritan Bennett, Inc.20053—
+2K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS…Cas Medical Systems, Inc.2005264—
+2K050583Model 250 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies20051—
+2K051367Patient Monitor, Models Dash 3000, 4000 and 5000Ge Medical Systems Information Technologies200591
+2K050919Lifegard II Family Multi-Function Patient Monitor, Models AN4320, AN4320P, AN4321P…Analogic Corp.20050—
+2K050175Spacelabs Medical Multiparameter Module 91496Spacelabs Medical, Inc.20052—
+2K042316Vanguard Reprocessed Pulse Oximeter SensorsVanguard Medical Concepts, Inc.20051—
+2K041867Hygia Health Services Reprocessed Oximax Sensors Model # HHS-Max-a, HHS-Max-AL, HHS-Max-NHygia Health Services, Inc.20042—
+2K032831Pro 2 Monitor, Pro 2 Sensor, PRO2 Holder, PRO2 Neonate Holder, Models, Pro- 200…Conmed Corporation20041—
+2K041204NC SP02 Adapter CableMasimo Corp.20040—
+2K040589Modification to Avant 9600 Pulse OximeterNonin Medical, Inc.200427—
+2K033048Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL…Cas Medical Systems, Inc.20042721
+2K033378Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc.20041083
+2K032363Zoll M Series Nibp OptionZoll Medical Corp2003114—
+2K031742Bci 6004 Nibp Monitor with Nellcor Pulse OximeterBci, Inc.200301
+2K030930Oximax Softcare Sensors, Models SC-a, SC-PR, SC-Neo, SC-NNellcor Puritan Bennett, Inc.20034—
+2K022163Welch Allyn Spot Vital Sign Monitor with MP506Welch Allyn, Inc.20020—
+2K022677Medley SPO2 Module, Model 8210 & SPO2 Sensors & CableAlaris Medical Systems, Inc.200202
+2K022193Dinamap Procare Series Monitor, Models 100N, 200N, 300N, 400NGe Medical Systems Information Technologies200221—
+2K021089Oximax Max-Fast Adhesive Forehead SensorNellcor Puritan Bennett, Inc.200213—
+2K021435Dinamap Pro Series Monitor, Models 110N,210N,310N,410NGe Medical Systems Information Technologies200201
+2K021090Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc.2002426—
+3K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd.20260—
+3K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+3K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…Unimed Medical Supplies, Inc.20250—
+3K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…Unimed Medical Supplies, Inc.20250—
+3K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…Unimed Medical Supplies, Inc.20250—
+3K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc.20251—
+3K202851Spo2 SensorJkh USA, LLC20201—
+3K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+3K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+3K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+3K181738Medline ReNewal Reprocessed OxiMax Pulse Oximetry SensorsSurgical Instrument Service and Savings Inc (Dba Medline20191—
+3K182822Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20196—
+3K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+3K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+3K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+3K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+3K173045OximeterShenzhen Greatmade Tech Limited20180—
+3K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+3K161909IQvitals ZoneMidmark Corporation201614
+3K160582WiCapAthena Gtx20160—
+3K152043Diagnostic Station DS20Schiller AG20161—
+3K152258T3 SoftwareEtiometry, Inc.201616—
+3K151940Thora-3Di, Model T-01Pneumacare Limited20163—
+3K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+3K142512Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq)20153—
+3K142865Nellcor Bedside SpO2 Patient Monitoring SystemCovidien, LLC201531
+3K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+3K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+3K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+3K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien201529—
+3K132407Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd.20141—
+3K141542Nellcor Portable SPO2 Patient Monitoring System ( Npspms )Covidien, LLC20140—
+3K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—