510(k) Report

Devices descending from K041411

120 later devices reach Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K230842SignalHF (IM008)Implicity, Inc.20230—
+8K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+8K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+8K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+8K221203AHI SystemFifth Eye, Inc.20220—
+8K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+9K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+9K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+9K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+9K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+9K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+9K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+9K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+10K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+10K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+10K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+10K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+10K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+10K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+10K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—