Cleared Traditional

Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use (K192679) - FDA 510(k) Clearance

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

K192679 · Gemtier Medical (Shanghai), Inc. · General Hospital
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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

Submission Details

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.

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

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 38
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