Cleared Traditional

K132553 - U&U STERILE PISTON SYRINGE WITHOUT NEEDLE

K132553 is an FDA 510(k) clearance for U&U STERILE PISTON SYRINGE WITHOUT NEEDLE, manufactured by U&U Medical Technology Co, Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K132553 · U&U Medical Technology Co, Ltd. · General Hospital
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Feb 2014
Decision
197d
Days
Class 2
Risk

K132553 is an FDA 510(k) clearance for the U&U STERILE PISTON SYRINGE WITHOUT NEEDLE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by U&U Medical Technology Co, Ltd. (Changzhou, Jiangsu, CN). The FDA issued a Cleared decision on February 27, 2014 after a review of 197 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 U&U Medical Technology Co, Ltd. devices

FDA 510(k) Submission Details - K132553

510(k) Number K132553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2013
Decision Date February 27, 2014
Days to Decision 197 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
68d slower than avg
Panel avg: 129d · This submission: 197d
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 480
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K132553.
NAMIC RCS SYRINGE
K140194 · Navilyst Medical, Inc. · Apr 2014
SINGLE USE STERILE SYRINGE WITH NEEDLE
K133493 · Jiangxi Kelun Medical Devices Manufacturing Co.,Lt · Mar 2014
APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET
K132011 · Aea Srl · Mar 2014
JMS SYRINGE
K132321 · JMS North America Corporation · Feb 2014
MIXING SYRINGE SYSTEM
K133021 · Zimmer Knee Creations, Inc. · Jan 2014
WTF SECURA SYRINGE AND NEEDLE
K132120 · Beijing Wantefu Medical Apparatus Co., Ltd. · Dec 2013