Cleared Traditional

K132120 - WTF SECURA SYRINGE AND NEEDLE

K132120 is an FDA 510(k) clearance for WTF SECURA SYRINGE AND NEEDLE, manufactured by Beijing Wantefu Medical Apparatus Co., Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K132120 · Beijing Wantefu Medical Apparatus Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
156d
Days
Class 2
Risk

K132120 is an FDA 510(k) clearance for the WTF SECURA SYRINGE AND NEEDLE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Beijing Wantefu Medical Apparatus Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on December 12, 2013 after a review of 156 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 Beijing Wantefu Medical Apparatus Co., Ltd. devices

FDA 510(k) Submission Details - K132120

510(k) Number K132120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2013
Decision Date December 12, 2013
Days to Decision 156 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
27d slower than avg
Panel avg: 129d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
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 - FMF Syringe, Piston

All 344
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K132120.
Merit 10mL Syringe
K142636 · Merit Medical Systems, Inc. · Oct 2014
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
K141762 · Biomet, Inc. · Aug 2014
NAMIC RCS SYRINGE
K140194 · Navilyst Medical, Inc. · Apr 2014
MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)
K131641 · Nipro Medical Corporation · Aug 2013
MONOJECT 12ML SYRINGE
K130049 · Nipro Medical Corporation · Feb 2013
BD EMERALD SAF-T SINGLE USE, HYPODERMIC
K121283 · Becton, Dickinson and Company · May 2012