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The Tracker / August 2026 / K261719

510(k) cleared

Promisemed X-Safety Pen Needle

Promisemed Hangzhou Meditech Co., Ltd. · Aug 25, 2026 · K261719

FDA cleared the Promisemed X-Safety Pen Needle from Promisemed Hangzhou Meditech Co., Ltd. on Aug 25, 2026 under K261719, a special 510(k). The device falls under product code FMI, Needle, Hypodermic, Single Lumen, regulated at 21 CFR 880.5570 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on May 26, 2026. The decision came 91 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Promisemed Hangzhou Meditech Co., Ltd. has 4 other decisions in the tracker over the last 12 months: K261196 (Promisemed VeriEcto Automatic Biopsy Needles), K261045 (Verifine Safety Lancets), K254273 (Verisafe Safety Sterile Needles (SSN)), K250192 (Verisafe Safety Retractable Insulin Syringes).

Questions & Answers

What did FDA clear under K261719?

K261719 is the FDA 510(k) for Promisemed X-Safety Pen Needle, submitted by Promisemed Hangzhou Meditech Co., Ltd.. FDA's decision date was Aug 25, 2026, under product code FMI (Needle, Hypodermic, Single Lumen).

Who makes the Promisemed X-Safety Pen Needle?

Promisemed Hangzhou Meditech Co., Ltd., based in Hangzhou, is the applicant of record for K261719.

How long did the K261719 review take?

FDA received the submission on May 26, 2026 and issued its decision on Aug 25, 2026, 91 days later.

← All decisions in August 2026

Sources