Cleared Traditional

UNIQSAFE ROTATABLE, RETRACTABLE SAFETY SYRINGES (K050116) - FDA 510(k) Clearance

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

K050116 · Uniqsafe Biomeditech Co., Ltd. · General Hospital
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May 2005
Decision
111d
Days
Class 2
Risk

K050116 is an FDA 510(k) clearance for the UNIQSAFE ROTATABLE, RETRACTABLE SAFETY SYRINGES. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Uniqsafe Biomeditech Co., Ltd. (Flagstaff, US). The FDA issued a Cleared decision on May 9, 2005 after a review of 111 days - within the typical 510(k) review window.

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 Uniqsafe Biomeditech Co., Ltd. devices

Submission Details

510(k) Number K050116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2005
Decision Date May 09, 2005
Days to Decision 111 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
18d faster than avg
Panel avg: 129d · This submission: 111d
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 37
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K050116.
Greenmedi Safety Filter Syringe
K173743 · Sang-A Frontec Co., Ltd. · Jan 2019
Self-destruction Safety Syringes for Single Use
K180417 · Berpu Medical Technology Co., Ltd. · Aug 2018
MEDLINE RETRACTABLE SAFETY SYRINGE
K101560 · Medline Industries, Inc. · Mar 2011
BECTON DICKINSON SYRINGE
K992734 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1999
HYPO(R) SAFETY CARTRIDGE SYRINGE
K936040 · Smith & Nephew, Inc. · May 1995