Cleared Traditional

K152808 - U&U Insulin Syringe with/without Safety Retractable Device

K152808 is an FDA 510(k) clearance for U&U Insulin Syringe with/without Safety..., manufactured by U&U Medical Technology Co, Ltd.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K152808 · U&U Medical Technology Co, Ltd. · General Hospital
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Mar 2016
Decision
179d
Days
Class 2
Risk

K152808 is an FDA 510(k) clearance for the U&U Insulin Syringe with/without Safety Retractable Device. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by U&U Medical Technology Co, Ltd. (Changzhou, CN). The FDA issued a Cleared decision on March 25, 2016 after a review of 179 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 - K152808

510(k) Number K152808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2015
Decision Date March 25, 2016
Days to Decision 179 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
50d slower than avg
Panel avg: 129d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEG Device Classification - Class 2, Special Controls

Product Code MEG Syringe, Antistick
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 - MEG Syringe, Antistick

All 91
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K152808.
NovaGuard SA Pro Safety System
K163511 · West Pharmaceutical Services, Inc. · Feb 2017
0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle
K162030 · Sol-Millennium Medical, Inc. · Aug 2016
Jeesung Safety Syringe and Single Use Needles
K152606 · Jeesung Medical Co., Ltd. · Jun 2016
Safety Auto-Disable Syrine with Needle (Auto-Lock)
K143497 · Guangdong Intmed Medical Appliance Co., Ltd. · Nov 2015
Disposable Safety Self-destructive Syringes, 5 ML
K143070 · Jiangsu Yile Medical Article Co., Ltd. · Jul 2015
Safe'n'Sound Staked Passive Delivery System - Plajex version
K150562 · Nemera · Jun 2015