Cleared Traditional

K132120 - WTF SECURA SYRINGE AND NEEDLE (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K132120 · Beijing Wantefu Medical Apparatus Co., Ltd. · General Hospital
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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

Submission Details

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.

Device Classification

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.

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