Cleared Traditional

K173743 - Greenmedi Safety Filter Syringe (FDA 510(k) Clearance)

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

K173743 · Sang-A Frontec Co., Ltd. · General Hospital
Jan 2019
Decision
417d
Days
Class 2
Risk

K173743 is an FDA 510(k) clearance for the Greenmedi Safety Filter Syringe. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Sang-A Frontec Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on January 28, 2019 after a review of 417 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

Submission Details

510(k) Number K173743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2017
Decision Date January 28, 2019
Days to Decision 417 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
248d slower than avg
Panel avg: 169d · This submission: 417d
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

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