Cleared Traditional

EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch? Safety Needle; EXEL Disposable Hypodermic Needle

K251089 · Exelint International, Co. · General Hospital

Dec 2025

Decision

246d

Days

Class 2

Risk

About This 510(k) Submission

K251089 is an FDA 510(k) clearance for the EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch? Safety Needle; EXEL Disposable Hypodermic Needle, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Exelint International, Co. (Redondo Beach, US). The FDA issued a Cleared decision on December 12, 2025, 246 days after receiving the submission on April 10, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K251089 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 2025
Decision Date	December 12, 2025
Days to Decision	246 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF