510(k) K251920

Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask by Dcstar, Inc. — Product Code BZD

K251920 is an FDA 510(k) premarket notification submitted by Dcstar, Inc. for the device "Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask". The FDA issued a decision of Substantially Equivalent on May 21, 2026. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Dcstar, Inc. has at least 1 other 510(k) clearance on record.