Cleared Traditional

K170651 - Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle

K170651 is an FDA 510(k) clearance for Sterile Disposable Syringe with Safety ..., manufactured by Yangzhou Medline Industry, Co., Ltd.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K170651 · Yangzhou Medline Industry, Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
152d
Days
Class 2
Risk

K170651 is an FDA 510(k) clearance for the Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe wit.... Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Yangzhou Medline Industry, Co., Ltd. (Yangzhou, CN). The FDA issued a Cleared decision on August 2, 2017 after a review of 152 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 Yangzhou Medline Industry, Co., Ltd. devices

FDA 510(k) Submission Details - K170651

510(k) Number K170651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2017
Decision Date August 02, 2017
Days to Decision 152 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
23d slower than avg
Panel avg: 129d · This submission: 152d
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 Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

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 140
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K170651.
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
Greenmedi Safety Filter Syringe
K173743 · Sang-A Frontec Co., Ltd. · Jan 2019
Self-destruction Safety Syringes for Single Use
K180417 · Berpu Medical Technology Co., Ltd. · Aug 2018
Sterile Hypodermic Safety Syringes for Single Use
K163162 · Jiangxi Hongda Medical Equipment Group , Ltd. · Mar 2017
NovaGuard SA Pro Safety System
K163511 · West Pharmaceutical Services, Inc. · Feb 2017
0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle
K162030 · Sol-Millennium Medical, Inc. · Aug 2016