Cleared Traditional

K252098 - PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252098 · Methyl Co., Ltd. · General Hospital
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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

Submission Details

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
102d slower than avg
Panel avg: 128d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K252098.
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