Cleared Traditional

K173743 - Greenmedi Safety Filter Syringe

K173743 is the FDA 510(k) clearance for Greenmedi Safety Filter Syringe by Sang-A Frontec Co., Ltd.. It is a Class 2 General Hospital device (product code MEG) cleared through the Traditional 510(k) pathway after a 417-day FDA review.

K173743 · Sang-A Frontec Co., Ltd. · General Hospital
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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.

View all Sang-A Frontec Co., Ltd. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
288d slower than avg
Panel avg: 129d · 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 Consultant

LK Consulting Group USA, Inc.
Priscilla Chung

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MEG Syringe, Antistick

All 41
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K173743.
Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe
K190183 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Oct 2019
Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe
K191490 · Jiangsu Caina Medical Co.,Ltd · Oct 2019
Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use
K183665 · Jiangsu Micsafe Medical Technology Co., Ltd. · Sep 2019
Self-destruction Safety Syringes for Single Use
K180417 · Berpu Medical Technology Co., Ltd. · Aug 2018
MEDLINE RETRACTABLE SAFETY SYRINGE
K101560 · Medline Industries, Inc. · Mar 2011
HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY
K072482 · Smiths Medical Asd, Inc. · Nov 2007