510(k) K202319

Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) by Tianjin Huahong Technology Co., Ltd. — Product Code FMI

K202319 is an FDA 510(k) premarket notification submitted by Tianjin Huahong Technology Co., Ltd. for the device "Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)". The FDA issued a decision of Substantially Equivalent on November 12, 2021. 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.