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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 621
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K132120.
U&U STERILE PISTON SYRINGE WITHOUT NEEDLE
K132553 · U&U Medical Technology Co, Ltd. · Feb 2014
JMS SYRINGE
K132321 · JMS North America Corporation · Feb 2014
MIXING SYRINGE SYSTEM
K133021 · Zimmer Knee Creations, Inc. · Jan 2014
STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES
K130230 · Wuxi Yushou Medical Applicances Co., Ltd. · Nov 2013
INFUSION SYRINGE SET
K131661 · Innovative Medical Manufacturing Co. · Nov 2013
TAUTONA INJECTOR DEVICE
K131963 · Tautona Group, LLC · Oct 2013
K132120 · WTF SECURA SYRINGE AND NEEDLE
Download PDF FDA Summary Beijing Wantefu Medic…