Cleared Traditional

PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)

K252098 · Methyl Co., Ltd. · General Hospital

Feb 2026

Decision

230d

Days

Class 2

Risk

About This 510(k) Submission

K252098 is an FDA 510(k) clearance for the PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED), a Syringe, Antistick (Class II — Special Controls, product code MEG), submitted by Methyl Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on February 18, 2026, 230 days after receiving the submission on July 3, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K252098 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2025
Decision Date	February 18, 2026
Days to Decision	230 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF