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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K050116.
EXEL SECURE TOUCH II SAFETY SYRINGE
K052103 · Exelint Intl. Co. · Oct 2005
TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR
K051865 · Terumo Medical Corp. · Sep 2005
SAF-T-SYRINGE/SAF-T-NEEDLE
K051762 · Safety Medical International, Incorporated · Sep 2005
P&P SAFETY SYRINGE
K043419 · Medexel Medical Mfg. Co., Ltd. · Apr 2005
INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE
K050131 · M.K. Meditech Co. , Ltd. · Apr 2005
ICC INSULIN SAFEPRO SAFETY SYRINGE
K050134 · Formosa Medical Devices, Inc. · Apr 2005
K050116 · UNIQSAFE ROTATABLE, RETRACTABLE SAFETY SYRINGES
Download PDF FDA Summary Uniqsafe Biomeditech …