510(k) K221836

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus by Drägerwerk AG & Co. KGaA — Product Code CAH

K221836 is an FDA 510(k) premarket notification submitted by Drägerwerk AG & Co. KGaA for the device "Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus". The FDA issued a decision of Substantially Equivalent on December 7, 2022. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Drägerwerk AG & Co. KGaA has at least 2 other 510(k) clearances on record.