Cleared Traditional

K143497 - Safety Auto-Disable Syrine with Needle (Auto-Lock)

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K143497.
0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle
K162030 · Sol-Millennium Medical, Inc. · Aug 2016
Jeesung Safety Syringe and Single Use Needles
K152606 · Jeesung Medical Co., Ltd. · Jun 2016
U&U Insulin Syringe with/without Safety Retractable Device
K152808 · U&U Medical Technology Co, Ltd. · Mar 2016
Disposable Safety Self-destructive Syringes, 5 ML
K143070 · Jiangsu Yile Medical Article Co., Ltd. · Jul 2015
Safe'n'Sound Staked Passive Delivery System - Plajex version
K150562 · Nemera · Jun 2015
Disposable sterile needle retractable safety syringe
K141349 · Guangdong Haiou Medical Apparatus Stock Co., Ltd. · Apr 2015
K143497 · Safety Auto-Disable Syrine with Needle (Auto-Lock)
Download PDF FDA Summary Guangdong Intmed Medi…