510(k) Report

Devices descending from K011869

82 later devices reach Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181286Ambu aScope RLS SlimAmbu A/S20186—
+1K070752Ksea Miniature Endoscope, Model 11565KARL STORZ Endoscopy-America, Inc.20076—
+1K040684T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation200467—
+1K032092Olympus Xcyf-TP3 Cystofiberscope/NephrofiberscopeOlympus Optical Co., Ltd.20030—
+2K243639Portare System (FA-001)Grumpy Innovation, Inc.20250—
+2K191080Ambu aScope 4 RhinoLaryngo SlimAmbu A/S20194—
+2K112826Noorvms-Oxy Tissue Oxygen and Temperture MonitorMoor Instruments, Ltd.20120—
+2K091452Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc.200957—
+2K083892Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc.200958—
+2K082569Entellus Medical Flexible Endoscope and EyepieceEntellus Medical, Inc.20085—
+2K081233T-Stat 303 Ischemia Monitoring SystemSpectros Corporation200856—
+2K073036Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc.200859—
+2K061960Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc.200659—
+2K051257Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc.200563—
+3K253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic…Zhuhai Wesee Meditech Co., Ltd.20260—
+3K232435Rhinolaryngoscope systemShenzhen HugeMed Medical Technical Development Co., Ltd.20240—
+3K214050ENT Nasopharyngoscope and AccessoriesMedimaging Integrated Solution, Inc (Miis)20220—
+3K220004Zsquare ENT-Flex EndoscopeZsquare, Ltd.20220—
+3K192322T-Stat 2.0 Microvascular Tissue OximeterSpectros Corporation20190—
+3K1629163NT endoscopy system3nt Medical, Ltd.20173—
+3K102366Finess EndoscopeEntellus Medical, Inc.20110—
+3K094030Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000…Cas Medical Systems, Inc.201053—
+3K102715Regional OximeterNonin Medical, Inc.201053—
+3K073407PacificaOr-Nim Medical, Ltd.20081—
+4K202727Peregrine Endoscopy System3nt Medical, Ltd.20210—
+4K192305Colibri Endoscopy System3nt Medical, Ltd.20200—
+4K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI…Nonin Medical, Inc.20190—
+4K151305SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model…Nonin Medical, Inc.20151—
+4K133879Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.201444—
+4K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+4K123700Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.20130—
+4K113215Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc.201242—
+4K112820Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc.201247—
+4K093923Cerox Model 3210Or-Nim Medical, Ltd.20100—
+5K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+5K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+5K160526Masimo O3 Regional Oximeter SystemMasimo Corporation20165—
+5K150268CerOXOr-Nim Medical, Ltd.20150—
+5K143675FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc.2015371
+6K233827OxiWearOxiwear, Inc.20240—
+6K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+6K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+6K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+6K182429Masimo O3 Regional Oximeter SystemMasimo Corporation20193—
+6K180003FORE-SIGHT ELITE Module Tissue OximeterCas Medical Systems, Inc.2018291
+6K162603Masimo O3 Regional Oximeter SystemMasimo Corporation20170—
+7K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+7K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+7K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+7K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+7K201432Masimo O3 Regional Oximeter SystemMasimo Corporation20202—
+7K190270FORE-SIGHT ELITE Tissue Oximeter ModuleCas Medical Systems, Inc.201915—
+8K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+8K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+8K233216CLEWICU SystemClew Medical, Ltd.20240—
+8K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+8K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+8K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+8K214072Masimo O3 Regional Oximeter SystemMasimo Corporation20221—
+8K212219AHI SystemFifth Eye, Inc.20211—
+8K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+8K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+8K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+9K260008Deterioration Index Version 2Epic Systems Corporation20260—
+9K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+9K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+9K243324Masimo O3 Regional OximeterMasimo Corporation20250—
+9K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+9K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+9K230842SignalHF (IM008)Implicity, Inc.20230—
+9K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+9K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+9K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+9K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+9K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+9K221203AHI SystemFifth Eye, Inc.20220—
+10K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+10K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+10K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+10K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+10K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+10K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—