Cleared Traditional

K093176 - MED-LOK

K093176 is an FDA 510(k) clearance for MED-LOK, manufactured by Sta-Med, LLC. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K093176 · Sta-Med, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
180d
Days
Class 2
Risk

K093176 is an FDA 510(k) clearance for the MED-LOK. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Sta-Med, LLC (Irvine, US). The FDA issued a Cleared decision on April 6, 2010 after a review of 180 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.

FDA 510(k) Submission Details - K093176

510(k) Number K093176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2009
Decision Date April 06, 2010
Days to Decision 180 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
51d slower than avg
Panel avg: 129d · This submission: 180d
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 K093176.
MED-LOK SAFETY NEEDLE
K103781 · Sta-Med, LLC · Feb 2011
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K100998 · Unilife Medical Solutions Limited · Aug 2010
INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES
K092413 · Inviro Medical Devices, Inc. · Sep 2009
1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES
K092430 · Inviro Medical Devices, Inc. · Sep 2009
1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2
K080877 · Unilife Medical Solutions Limited · Oct 2008
K093176 · MED-LOK
Download PDF FDA Summary Sta-Med, LLC