510(k) Report

Devices descending from K051212

85 later devices reach Modification to LNCS Oximetry Sensors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+1K102560Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20110—
+1K101031Masimo Disposable Oximetry Ear Sensor, Model E1Masimo Corporation20105—
+1K101896Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation201062—
+1K101280Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeMidwest Reprocessing Center, LLC20100—
+1K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation201039—
+1K092368Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20090—
+1K090662Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ DbipMasimo Corporation200911
+1K083719LNCS Oximetry SensorsMasimo Corporation20092—
+1K083622LNCS Oximetry SensorsMasimo Corporation20091—
+1K080424Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and…Hygia Health Services, Inc.20081—
+1K060143LNCS and SPO2.Com SensorsMasimo Corporation200610—
+2K211140Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse…Stryker Sustainability Solutions20222—
+2K191018Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive SensorsSurgical Instrument Service and Savings, Inc.20190—
+2K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+2K140430740 SelectCas Medical Systems, Inc.20141—
+2K121912E1 Ear SensorsMasimo Corporation20124—
+2K113596Masimo Set Reusable Oximetry SensorsMasimo Corporation20120—
+2K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation201138—
+2K111888Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation201159—
+2K110723M-LNCS Oximetry Sensors, Reprocessed M-LNCS Oximetry SensorsMasimo Corporation20110—
+2K094046LNCS Oximetry Sensors, Reprocessed LNCS Oximetry SensorsMasimo Corporation20100—
+2K081238Reprocessed Masimo Pulse Oximeter SensorsAscent Healthcare Solutions20083—
+3K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+3K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.20175—
+3K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+3K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+3K150620740 SelectCas Medical Systems, Inc.201501
+3K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.201514—
+3K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale20133—
+4K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd.20260—
+4K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+4K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…Unimed Medical Supplies, Inc.20250—
+4K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…Unimed Medical Supplies, Inc.20250—
+4K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…Unimed Medical Supplies, Inc.20250—
+4K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc.20251—
+4K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+4K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+4K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+4K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+4K202851Spo2 SensorJkh USA, LLC20201—
+4K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+4K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+4K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+4K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+4K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+4K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+4K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+4K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+4K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+4K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+4K173368Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd.20180—
+4K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+4K173045OximeterShenzhen Greatmade Tech Limited20180—
+4K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+4K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+4K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+4K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+5K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+5K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+5K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+5K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+5K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+5K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+5K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+5K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+5K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20200—
+5K192608Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd20200—
+5K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+5K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+5K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+6K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+6K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—
+6K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+6K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+6K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+6K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+6K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+6K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+7K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+7K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+7K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+8K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+8K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+8K253034HemoSphere Stream ModuleEdwards Lifesciences20250—