Cleared Traditional

K132553 - U&U STERILE PISTON SYRINGE WITHOUT NEEDLE (FDA 510(k) Clearance)

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

K132553 · U&U Medical Technology Co, Ltd. · General Hospital
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.

Submission Details

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
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 169d · This submission: 197d
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.

Regulatory Peers - FMF Syringe, Piston

All 29
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K132553.
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