Cleared Traditional

K143497 - Safety Auto-Disable Syrine with Needle ...

K143497 is an FDA 510(k) clearance for Safety Auto-Disable Syrine with Needle ..., manufactured by Guangdong Intmed Medical Appliance Co., Ltd.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K143497 · Guangdong Intmed Medical Appliance Co., Ltd. · General Hospital
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Nov 2015
Decision
330d
Days
Class 2
Risk

K143497 is an FDA 510(k) clearance for the Safety Auto-Disable Syrine with Needle (Auto-Lock). Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Guangdong Intmed Medical Appliance Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on November 4, 2015 after a review of 330 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Guangdong Intmed Medical Appliance Co., Ltd. devices

FDA 510(k) Submission Details - K143497

510(k) Number K143497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2014
Decision Date November 04, 2015
Days to Decision 330 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
201d slower than avg
Panel avg: 129d · This submission: 330d
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 Peers - MEG Syringe, Antistick

All 43
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K143497.
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
MEDLINE RETRACTABLE SAFETY SYRINGE
K101560 · Medline Industries, Inc. · Mar 2011
ULTICARE SAFETY INSULIN SYRINGE
K103011 · Ulti-Med Intl., Inc. · Feb 2011
HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY
K072482 · Smiths Medical Asd, Inc. · Nov 2007