Cleared Traditional

Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use (K183665) - FDA 510(k) Clearance

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

K183665 · Jiangsu Micsafe Medical Technology Co., Ltd. · General Hospital
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Sep 2019
Decision
253d
Days
Class 2
Risk

K183665 is an FDA 510(k) clearance for the Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile .... Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Jiangsu Micsafe Medical Technology Co., Ltd. (Yancheng, CN). The FDA issued a Cleared decision on September 6, 2019 after a review of 253 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 Jiangsu Micsafe Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K183665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2018
Decision Date September 06, 2019
Days to Decision 253 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
124d slower than avg
Panel avg: 129d · This submission: 253d
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

All 38
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K183665.
Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use
K192679 · Gemtier Medical (Shanghai), Inc. · Apr 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
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
MEDLINE RETRACTABLE SAFETY SYRINGE
K101560 · Medline Industries, Inc. · Mar 2011