Cleared Traditional

Promisemed Insulin Pen Needle

K210059 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
Jul 2021
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K210059 is an FDA 510(k) clearance for the Promisemed Insulin Pen Needle, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on July 21, 2021, 191 days after receiving the submission on January 11, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K210059 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 2021
Decision Date July 21, 2021
Days to Decision 191 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMI — Needle, Hypodermic, Single Lumen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

Similar Devices — FMI Needle, Hypodermic, Single Lumen

All 684
Pen Needle
K252886 · Hh Global Technology, Inc. · Jan 2026
Pen Injector Needle 32.5
K250700 · Terumo Corporation · Nov 2025
Profoject? Disposable Needle
K252631 · CMT Health PTE., Ltd. · Oct 2025
Intraosseous Infusion Needles
K250724 · Spectrum Vascular · Jul 2025
TSK SELECT? Needle
K250284 · Tsk Laboratory, Japan · Jul 2025
K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
K251447 · Terumo Europe N.V. · Jul 2025