Cleared Traditional

K113587 - AUTOMATICALLY RETRACTABLE SAFETY SYRING...

K113587 is an FDA 510(k) clearance for AUTOMATICALLY RETRACTABLE SAFETY SYRING..., manufactured by Shantou Wealy Medical Instrument Co.,Ltd. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K113587 · Shantou Wealy Medical Instrument Co.,Ltd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
81d
Days
Class 2
Risk

K113587 is an FDA 510(k) clearance for the AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE). Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Shantou Wealy Medical Instrument Co.,Ltd (Echo, US). The FDA issued a Cleared decision on February 24, 2012 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shantou Wealy Medical Instrument Co.,Ltd devices

FDA 510(k) Submission Details - K113587

510(k) Number K113587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2011
Decision Date February 24, 2012
Days to Decision 81 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
48d faster than avg
Panel avg: 129d · This submission: 81d
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 42
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K113587.
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
HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY
K072482 · Smiths Medical Asd, Inc. · Nov 2007
PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
K063755 · Smiths Medical Asd, Inc. · Feb 2007