510(k) K251572

eRapid with eTrack System by Pari Respiratory Equipment, Inc. — Product Code CAF

K251572 is an FDA 510(k) premarket notification submitted by Pari Respiratory Equipment, Inc. for the device "eRapid with eTrack System". The FDA issued a decision of Substantially Equivalent on December 19, 2025. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Pari Respiratory Equipment, Inc. has at least 9 other 510(k) clearances on record.