510(k) K253186

HemoSphere Nano Monitor (HSNANO1) by Edwards Lifesciences, LLC — Product Code DQK

K253186 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "HemoSphere Nano Monitor (HSNANO1)". The FDA issued a decision of Substantially Equivalent on February 24, 2026. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.