Cleared Traditional

K192679 - Sterile Syringe with Safety needle for ...

K192679 is an FDA 510(k) clearance for Sterile Syringe with Safety needle for ..., manufactured by Gemtier Medical (Shanghai), Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K192679 · Gemtier Medical (Shanghai), Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
197d
Days
Class 2
Risk

K192679 is an FDA 510(k) clearance for the Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single.... Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Gemtier Medical (Shanghai), Inc. (Shanghai, CN). The FDA issued a Cleared decision on April 10, 2020 after a review of 197 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 Gemtier Medical (Shanghai), Inc. devices

FDA 510(k) Submission Details - K192679

510(k) Number K192679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2019
Decision Date April 10, 2020
Days to Decision 197 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
68d slower than avg
Panel avg: 129d · This submission: 197d
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 41
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K192679.
TK Insulin Syringe with/without Saftey Retractable Device
K191639 · Anhui Tiankang Medical Technology Co., Ltd. · Sep 2020
1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle
K192551 · Jiangsu Caina Medical Co.,Ltd · Aug 2020
Retractable Safety Insulin Syringe
K193022 · Jiangsu Caina Medical Co.,Ltd · Jul 2020
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