Cleared Traditional

K252098 - PA3X Detachable Safety Sleeve Syringe (...

K252098 is an FDA 510(k) clearance for PA3X Detachable Safety Sleeve Syringe (..., manufactured by Methyl Co., Ltd.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K252098 · Methyl Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
230d
Days
Class 2
Risk

K252098 is an FDA 510(k) clearance for the PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED). Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Methyl Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on February 18, 2026 after a review of 230 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Methyl Co., Ltd. devices

FDA 510(k) Submission Details - K252098

510(k) Number K252098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 129d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEG Device Classification - Class 2, Special Controls

Product Code MEG Syringe, Antistick
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - MEG Syringe, Antistick

All 41
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K252098.
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