510(k) Report

Devices descending from K991823

785 later devices reach N-395 Pulse Oximeter, Model N-395 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133064Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip Large R-3211-31, Finger…Envitec-Wismar GmbH20140—
+1K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale20133—
+1K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG2010312
+1K092641Charmcare Tabletop Pulse OximeterCharmcare Co., Ltd.20100—
+1K083892Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc.200958—
+1K073036Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc.200859—
+1K052544Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc.20060—
+1K051212Modification to LNCS Oximetry SensorsMasimo Corporation2005855
+1K040684T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation200467—
+1K041522Flexi-Stat Disposable Adhesive SPO2 SensorsElekon Industries U.S.A., Inc.20042—
+1K041964Mediaid Reusable Finger Clip SPO2 Sensors and Disposable Non-Adhesive Sensors and…Mediaid, Inc.20040—
+1K041647Flexi-Stat Reusable Finger Clip SPO2 Sensors (Nellcor-Compatible),(Bci-Compatible)…Elekon Industries U.S.A., Inc.20042—
+1K033349AC-1 SP02 Adaptor Cable, Model AC-1Masimo Corp.20042—
+1K033298SPO2.Com Oximetry Sensors, Multiple ModelsMasimo Corp.200395—
+1K032947Nellcor Compatible Dolphin 2000 Y Oximetry Sensor, Model 2210Dolphin Medical, Inc.20031—
+1K030952Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312 Pediatric, 2313…Dolphin Medical, Inc.20033—
+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—
+1K993979MARSPO2, Model 2001Novametrix Medical Systems, Inc.20002551
+2K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG20240—
+2K212555Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult…Covidien, LLC20220—
+2K211138Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L)…Stryker Sustainability Solutions20220—
+2K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc.20170—
+2K162014Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2…Bluepoint Medical GmbH & Co. KG20170—
+2K152973Dyna-Vision Telemonitoring SystemTechmedic Development International B.V.20160—
+2K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…Sentec AG201519
+2K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+2K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+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
+2K112826Noorvms-Oxy Tissue Oxygen and Temperture MonitorMoor Instruments, Ltd.20120—
+2K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+2K113054EquivitalHidalgo Limited201271—
+2K102560Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20110—
+2K101031Masimo Disposable Oximetry Ear Sensor, Model E1Masimo Corporation20105—
+2K101896Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation201062—
+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—
+2K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation201039—
+2K093261MOVESThornhill Research, Inc.20107Class I
+2K100020DX Series Finger SensorDixtal Medical, 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—
+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
+2K083622LNCS Oximetry SensorsMasimo Corporation20091—
+2K081233T-Stat 303 Ischemia Monitoring SystemSpectros Corporation200856—
+2K081140VisensiaObs Medical200822—
+2K080424Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and…Hygia Health Services, Inc.20081—
+2K070377Giraffe and Panda WarmerOhmeda Medical20073Class I
+2K070408Duramax Reusable Oximetry SensorNellcor Puritan Bennett, Inc.20070—
+2K061993Equivital, Model EQ-01Hidalgo Limited200699—
+2K061960Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc.200659—
+2K060576Nellcor Oximax N-600X Pulse OximeterNellcor Puritan Bennett, Inc.2006140—
+2K060143LNCS and SPO2.Com SensorsMasimo Corporation200610—
+2K060524Dolphin 2000 Datex Compatible Oximetry Disposable and Reusable Sensors and Extension…Dolphin Medical, Inc.20060—
+2K061191Finger and Ear Sensors and Neonatal-Adult and Adult/Pediatric Adhesive Sensors for Use…Measurement Specialties, Inc.20060—
+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—
+2K051257Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc.200563—
+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—
+2K050252AC-1 Adapter Cable, 8 Pin and 12 Pin PhilipsMasimo Corporation20050—
+2K050175Spacelabs Medical Multiparameter Module 91496Spacelabs Medical, Inc.20052—
+2K043463Envitec Reusable Multi-Site Y SPO2 SensorsEnvitec-Wismar GmbH20055—
+2K042316Vanguard Reprocessed Pulse Oximeter SensorsVanguard Medical Concepts, Inc.20051—
+2K042705Disposable Non-Adhesive SPO2 SensorsElekon Industries U.S.A., Inc.20041—
+2K033973Oxisensor II Recycled Sensor and Oximax Recycled SensorNellcor Puritan Bennett, Inc.20041—
+2K042704Reusable Finger Clip SPO2 SensorsElekon Industries U.S.A., Inc.20041—
+2K042346LNCS Oximetry SensorsMasimo Corporation20041—
+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—
+2K041815LNCS Oximetry SensorsMasimo Corp.200486—
+2K041204NC SP02 Adapter CableMasimo Corp.20040—
+2K033048Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL…Cas Medical Systems, Inc.20042721
+2K032755Model 509M Pulse Oximeter, Model 509MRespironics Novametrix, Inc.200401
+2K033876Dolphin 2000 Oximetry Sensors, Models 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342…Dolphin Medical, Inc.20040—
+2K033378Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc.20041083
+2K032363Zoll M Series Nibp OptionZoll Medical Corp2003114—
+2K030886Nico with Mars, Model 7300Respironics Novametrix, Inc.20032468
+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—