510(k) K254123

Ecomed Disposable Administration Sets by Ecomed Solutions, LLC — Product Code FPA

K254123 is an FDA 510(k) premarket notification submitted by Ecomed Solutions, LLC for the device "Ecomed Disposable Administration Sets". The FDA issued a decision of Substantially Equivalent on September 11, 2026. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Ecomed Solutions, LLC has at least 2 other 510(k) clearances on record.