510(k) Report

Devices descending from K863784

273 later devices reach Nellcor N-200 (Pulse Oximeter) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101280Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeMidwest Reprocessing Center, LLC20100—
+1K060576Nellcor Oximax N-600X Pulse OximeterNellcor Puritan Bennett, Inc.2006140—
+1K051212Modification to LNCS Oximetry SensorsMasimo Corporation2005855
+1K041964Mediaid Reusable Finger Clip SPO2 Sensors and Disposable Non-Adhesive Sensors and…Mediaid, Inc.20040—
+1K041867Hygia Health Services Reprocessed Oximax Sensors Model # HHS-Max-a, HHS-Max-AL, HHS-Max-NHygia Health Services, Inc.20042—
+1K041204NC SP02 Adapter CableMasimo Corp.20040—
+1K033349AC-1 SP02 Adaptor Cable, Model AC-1Masimo Corp.20042—
+1K033298SPO2.Com Oximetry Sensors, Multiple ModelsMasimo Corp.200395—
+1K030952Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312 Pediatric, 2313…Dolphin Medical, Inc.20033—
+1K012677Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20031—
+1K022819Nellcor N-200 Pulse Oximeter, Model N-200Nellcor Puritan Bennett, Inc.2002141—
+1K971946NPB-190 Pulse Oximeter (NPB-190)Nellcor Puritan Bennett, Inc.19971—
+1K952315Satmaster, Computerized Pulse Oximetry SoftwareEmg Scientific19960—
+1K960614Somanetics Invos 3100A Cerebral Oximeter (Invos)Somanetics Corp.199667—
+2K161909IQvitals ZoneMidmark Corporation201614
+2K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+2K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+2K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+2K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+2K111007Midwest Reprocessing Center Reprocessed LNCS Sessors; Midwest Reprocessing Center…Midwest Reprocessing Center, LLC20110—
+2K102560Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20110—
+2K103166Cheetah ReliantCheetah Medical, Inc.20111—
+2K101031Masimo Disposable Oximetry Ear Sensor, Model E1Masimo Corporation20105—
+2K101896Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation201062—
+2K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation201039—
+2K100523Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model…Hygia Health Services, Inc.20100—
+2K092368Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20090—
+2K091452Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc.200957—
+2K083448Cable, Transducer, Model 2400GNConmed Corporation20090—
+2K090662Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ DbipMasimo Corporation200911
+2K083719LNCS Oximetry SensorsMasimo Corporation20092—
+2K090360Philips M3001A Multi Measurement ServerPhilips Medizin Systeme Boblingen GmbH200984—
+2K083622LNCS Oximetry SensorsMasimo Corporation20091—
+2K083892Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc.200958—
+2K083325N-600X with SPD, Oximax N-600XCovidien200953—
+2K080424Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and…Hygia Health Services, Inc.20081—
+2K073036Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc.200859—
+2K070377Giraffe and Panda WarmerOhmeda Medical20073Class I
+2K052544Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc.20060—
+2K061960Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc.200659—
+2K060143LNCS and SPO2.Com SensorsMasimo Corporation200610—
+2K060524Dolphin 2000 Datex Compatible Oximetry Disposable and Reusable Sensors and Extension…Dolphin Medical, Inc.20060—
+2K051257Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc.200563—
+2K050583Model 250 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies20051—
+2K050252AC-1 Adapter Cable, 8 Pin and 12 Pin PhilipsMasimo Corporation20050—
+2K041127Modification to: Reprocessed Oximax Pulse Oximeter SensorsSterilmed, Inc.20040—
+2K042346LNCS Oximetry SensorsMasimo Corporation20041—
+2K041815LNCS Oximetry SensorsMasimo Corp.200486—
+2K033876Dolphin 2000 Oximetry Sensors, Models 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342…Dolphin Medical, Inc.20040—
+2K032947Nellcor Compatible Dolphin 2000 Y Oximetry Sensor, Model 2210Dolphin Medical, Inc.20031—
+2K971628Somanetics Invos 3100A Cerebral Oximeter (Invos)Somanetics Corp.19972—
+3K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+3K211140Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse…Stryker Sustainability Solutions20222—
+3K191018Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive SensorsSurgical Instrument Service and Savings, Inc.20190—
+3K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+3K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+3K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+3K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+3K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+3K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+3K140430740 SelectCas Medical Systems, Inc.20141—
+3K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+3K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+3K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+3K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+3K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+3K123309Giraffe and Panda WarmersOhmeda Medical20130Class I
+3K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien201245—
+3K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+3K121912E1 Ear SensorsMasimo Corporation20124—
+3K120773Nellcor Bedside SPO2 Patient Monitoring SystemCovidien, LLC201261
+3K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien201249—
+3K113596Masimo Set Reusable Oximetry SensorsMasimo Corporation20120—
+3K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation201138—
+3K111888Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation201159—
+3K110723M-LNCS Oximetry Sensors, Reprocessed M-LNCS Oximetry SensorsMasimo Corporation20110—
+3K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+3K094030Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000…Cas Medical Systems, Inc.201053—
+3K102715Regional OximeterNonin Medical, Inc.201053—
+3K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+3K094046LNCS Oximetry Sensors, Reprocessed LNCS Oximetry SensorsMasimo Corporation20100—
+3K090697Modification to: Giraffe and Panda WarmerOhmeda Medical20091Class I
+3K081238Reprocessed Masimo Pulse Oximeter SensorsAscent Healthcare Solutions20083—
+3K073407PacificaOr-Nim Medical, Ltd.20081—
+3K072976Model 250CX Series Maternal/Fetal MonitorGE Healthcare20070—
+3K072157Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)Ohmeda Medical200721
+3K050068Lnopv AD-L and PD-L Oximetry SensorsMasimo Corporation20050—
+4K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+4K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—
+4K242798AirmodHeroic Faith International, Ltd.20251—
+4K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+4K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+4K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+4K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI…Nonin Medical, Inc.20190—
+4K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+4K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.20175—
+4K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+4K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+4K151305SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model…Nonin Medical, Inc.20151—
+4K150620740 SelectCas Medical Systems, Inc.201501