510(k) K242909

FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors by Edwards Lifesciences, LLC — Product Code DRS

K242909 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors". The FDA issued a decision of Substantially Equivalent on March 21, 2025. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.