Cleared Special

CLICKFINE PEN NEEDLE

K102108 · Ypsomed AG · General Hospital
Nov 2010
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K102108 is an FDA 510(k) clearance for the CLICKFINE PEN NEEDLE, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Ypsomed AG (Burgdorf, CH). The FDA issued a Cleared decision on November 23, 2010, 119 days after receiving the submission on July 27, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K102108 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 2010
Decision Date November 23, 2010
Days to Decision 119 days
Submission Type Special
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