510(k) K251326

Respiration Rate algorithm by Edwards Lifesciences, LLC — Product Code BZQ

K251326 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "Respiration Rate algorithm". The FDA issued a decision of Substantially Equivalent on June 11, 2026. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.