510(k) Report

Devices descending from K921707

258 later devices reach Pentax Naso-Pharyngo-Laryngoscope FNL-15P2/15RP2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc.20160—
+8K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation20260—
+8K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…Fujifilm Corporation20250—
+8K250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal…Olympus Medical Systems Corporation20250—
+8K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…Pentax of America, Inc.20240—
+8K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+8K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+8K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20223—
+8K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton20213—
+8K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210—
+8K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+8K202469G-EYE SystemSmart Medical Systems, Ltd.20201—
+8K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+8K201432Masimo O3 Regional Oximeter SystemMasimo Corporation20202—
+8K202130FUJIFILM Video LaparoscopeFujifilm Corporation20201—
+8K190270FORE-SIGHT ELITE Tissue Oximeter ModuleCas Medical Systems, Inc.201915—
+9K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20251—
+9K250268HyperSnap Surgical System (HSS)Hypervision Surgical20251—
+9K250900EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20250—
+9K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+9K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+9K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+9K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+9K233216CLEWICU SystemClew Medical, Ltd.20240—
+9K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+9K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+9K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+9K214072Masimo O3 Regional Oximeter SystemMasimo Corporation20221—
+9K220158G-EYE SystemSmart Medical Systems, Ltd.20220—
+9K212219AHI SystemFifth Eye, Inc.20211—
+9K212950FUJIFILM Video Laparoscope EL-R740M30Fujifilm Corporaton20210—
+9K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+9K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+9K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+10K260008Deterioration Index Version 2Epic Systems Corporation20260—
+10K253984Instrument Exit Point on Touch Surgery™ AideCovidien, LLC20260—
+10K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.20260—
+10K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+10K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+10K243324Masimo O3 Regional OximeterMasimo Corporation20250—
+10K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+10K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+10K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+10K230842SignalHF (IM008)Implicity, Inc.20230—
+10K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+10K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+10K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+10K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+10K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+10K221203AHI SystemFifth Eye, Inc.20220—
+11K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+11K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+11K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+11K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+11K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+11K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+11K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+12K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—