510(k) K261719

Promisemed X-Safety Pen Needle by Promisemed Hangzhou Meditech Co., Ltd. — Product Code FMI

K261719 is an FDA 510(k) premarket notification submitted by Promisemed Hangzhou Meditech Co., Ltd. for the device "Promisemed X-Safety Pen Needle". The FDA issued a decision of Substantially Equivalent on August 25, 2026. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Promisemed Hangzhou Meditech Co., Ltd. has at least 10 other 510(k) clearances on record.