510(k) Report

Devices descending from K850978

433 later devices reach Olympus LF-1 Intubation Scope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+10K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+10K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…Edwards Lifesciences, LLC202118—
+10K190639Endosee SystemCooperSurgical, Inc.201931
+10K160510MAKO 7Nvision Medical Corporation20161—
+11K260008Deterioration Index Version 2Epic Systems Corporation20260—
+11K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+11K252806Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US…Shanghai AnQing Medical Instrument Co., Ltd.20250—
+11K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+11K243324Masimo O3 Regional OximeterMasimo Corporation20250—
+11K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+11K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+11K240978SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G…MacroLux Medical Technology Co., Ltd.20241—
+11K241987Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)Guangzhou Red Pine Medical Instrument Co., Ltd.20240—
+11K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+11K230842SignalHF (IM008)Implicity, Inc.20230—
+11K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+11K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+11K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+11K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+11K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+11K221203AHI SystemFifth Eye, Inc.20220—
+11K200038Endosee SystemCooperSurgical, Inc.20201—
+11K182975MAKO 7Boston Scientific Corporation20190—
+12K254294Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A…Zhejiang Geyi Medical Instrument Co., Ltd.20260—
+12K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+12K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd.20260—
+12K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+12K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+12K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+12K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+12K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+12K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—