510(k) K221176

Insulin Pen Needle by Tianjin Huahong Technology Co., Ltd. — Product Code FMI

K221176 is an FDA 510(k) premarket notification submitted by Tianjin Huahong Technology Co., Ltd. for the device "Insulin Pen Needle". The FDA issued a decision of Substantially Equivalent on July 1, 2022. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Tianjin Huahong Technology Co., Ltd. has at least 10 other 510(k) clearances on record.