510(k) K213183

Safety Insulin Pen Needles by Zhejiang Kindly Medical Devices Co., Ltd. — Product Code FMI

K213183 is an FDA 510(k) premarket notification submitted by Zhejiang Kindly Medical Devices Co., Ltd. for the device "Safety Insulin Pen Needles". The FDA issued a decision of Substantially Equivalent on October 14, 2022. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Zhejiang Kindly Medical Devices Co., Ltd. has at least 4 other 510(k) clearances on record.