FDA cleared the HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) from Edwards Lifesciences on Dec 18, 2025 under K252533, a traditional 510(k). The device falls under product code DQK, Computer, Diagnostic, Programmable, regulated at 21 CFR 870.1425 as a Class 2 device. The review panel was Cardiovascular.
FDA logged the submission as received on Aug 12, 2025. The decision came 128 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Edwards Lifesciences has 8 other decisions in the tracker over the last 12 months: K254232 (ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)), K251326 (Respiration Rate algorithm), K260105 (Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts), K254279 (Edwards eSheath+ introducer set).