Cleared Traditional

K131531 - TIANKANG DISPOSABLE SYRINGES WITH RE-US...

K131531 is an FDA 510(k) clearance for TIANKANG DISPOSABLE SYRINGES WITH RE-US..., manufactured by Anhui Tiankang Medical Products Co., Ltd.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 349-day FDA review.

K131531 · Anhui Tiankang Medical Products Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
May 2014
Decision
349d
Days
Class 2
Risk

K131531 is an FDA 510(k) clearance for the TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT N.... Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Anhui Tiankang Medical Products Co., Ltd. (Tianchang City, Anhui Province, CN). The FDA issued a Cleared decision on May 12, 2014 after a review of 349 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 Anhui Tiankang Medical Products Co., Ltd. devices

FDA 510(k) Submission Details - K131531

510(k) Number K131531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2013
Decision Date May 12, 2014
Days to Decision 349 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
220d slower than avg
Panel avg: 129d · This submission: 349d
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 K131531.
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