510(k) K251888

VPAP Pediatric Face Mask by Hsiner Co., Ltd. — Product Code CBK

K251888 is an FDA 510(k) premarket notification submitted by Hsiner Co., Ltd. for the device "VPAP Pediatric Face Mask". The FDA issued a decision of Substantially Equivalent on March 12, 2026. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Hsiner Co., Ltd. has at least 6 other 510(k) clearances on record.