Cleared Traditional

Pen Injector Needle 32.5

K250700 · Terumo Corporation · General Hospital
Nov 2025
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K250700 is an FDA 510(k) clearance for the Pen Injector Needle 32.5, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Terumo Corporation (Shibuya-Ku, Tokyo, JP). The FDA issued a Cleared decision on November 21, 2025, 259 days after receiving the submission on March 7, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K250700 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2025
Decision Date November 21, 2025
Days to Decision 259 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

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