510(k) K230559

Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) by Medline Industries, Inc. — Product Code BTT

K230559 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)". The FDA issued a decision of Substantially Equivalent on October 26, 2023. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.