510(k) Report

Devices descending from K043065

18 later devices reach Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor, Models MIHM1 and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181372ArgosRetia Medical, LLC20182—
+1K152980Flo Trac sensor, Volume View sensorEdwards Lifesciences, LLC201674
+1K101518Compass Vascular Access; Compass Lumbar PunctureMirador Biomedical, Inc.20106—
+2K254074TruPressProcerus Enterprises20260—
+2K253092Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc.20260—
+2K251275VitalStream ART Connect; VitalStream-HemoCaretaker Medical20250—
+2K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+2K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+2K133624Compass CT, Compass CT PortMirador Biomedical20141—
+2K112203Compass Global Pressure, Compass Thoracentesis, Paracentesis, Compartment Pressure…Mirador Biomedical, Inc.20114—
+3K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+3K161408Compass Cast and MAPCenturion Medical Products Corporation20160—
+3K142245EpiAccess SystemEpiep, Inc.20141—
+4K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+4K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+4K170831EpiAccess SystemEpiep, Inc.20170—
+5K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+5K253034HemoSphere Stream ModuleEdwards Lifesciences20250—