Cleared Traditional

Pen Needle

K252886 · Hh Global Technology, Inc. · General Hospital

Jan 2026

Decision

118d

Days

Class 2

Risk

About This 510(k) Submission

K252886 is an FDA 510(k) clearance for the Pen Needle, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Hh Global Technology, Inc. (Buford, US). The FDA issued a Cleared decision on January 6, 2026, 118 days after receiving the submission on September 10, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K252886 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 2025
Decision Date	January 06, 2026
Days to Decision	118 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF