Cleared Traditional

U&U Insulin Syringe with/without Safety Retractable Device (K152808) - FDA 510(k) Clearance

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

K152808 · U&U Medical Technology Co, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

Device Classification

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 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K152808.
PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)
K252098 · Methyl Co., Ltd. · Feb 2026
VaporShield
K250847 · Vault Paragon Group, Inc. · Dec 2025
SaviSafe Safety Device
K230287 · Suzhou Savicred Biotechnology Co., Ltd. · Nov 2023
Shina Syringe
K231165 · Shina Med Corporation · Oct 2023
Medline Safety Insulin and TB Syringes
K231907 · Medline Industries, LP · Oct 2023
Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110)
K223376 · Cardinal Health200, LLC · Jun 2023