510(k) K251631

The BAG manual resuscitator and accessories by Laerdal Medical AS — Product Code BTM

K251631 is an FDA 510(k) premarket notification submitted by Laerdal Medical AS for the device "The BAG manual resuscitator and accessories". The FDA issued a decision of Substantially Equivalent on November 24, 2025. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Laerdal Medical AS has at least 10 other 510(k) clearances on record.