Cleared Traditional

K050116 - UNIQSAFE ROTATABLE, RETRACTABLE SAFETY SYRINGES

K050116 is an FDA 510(k) clearance for UNIQSAFE ROTATABLE, manufactured by Uniqsafe Biomeditech Co., Ltd.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 111-day FDA review.

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

FDA 510(k) Submission Details - K050116

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.

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 62
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K050116.
PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
K063755 · Smiths Medical Asd, Inc. · Feb 2007
PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558
K061194 · Smiths Medical Asd, Inc. · Aug 2006
TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR
K051865 · Terumo Medical Corp. · Sep 2005
TERUMO SURGUARD SAFETY SYRINGE
K024249 · Terumo Medical Corp. · Feb 2003
UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE
K993996 · Univec, Inc. · Jul 2000
SOLOGUARD LOCKING PLUS SYRINGE
K993609 · Safeguard Medical Products, Inc. · Mar 2000