Cleared Special

K103781 - MED-LOK SAFETY NEEDLE

K103781 is an FDA 510(k) clearance for MED-LOK SAFETY NEEDLE, manufactured by Sta-Med, LLC. The device is a Class 2 General Hospital device with product code MEG cleared through the Special 510(k) pathway after a 43-day FDA review.

K103781 · Sta-Med, LLC · General Hospital
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Feb 2011
Decision
43d
Days
Class 2
Risk

K103781 is an FDA 510(k) clearance for the MED-LOK SAFETY NEEDLE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Sta-Med, LLC (Anaheim, US). The FDA issued a Cleared decision on February 8, 2011 after a review of 43 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K103781

510(k) Number K103781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2010
Decision Date February 08, 2011
Days to Decision 43 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 129d · This submission: 43d
Pathway characteristics
Modification to existing cleared device.

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 K103781.
MYSAFETY SYRINGE
K111734 · Medicalchain Intl. Corp. · Sep 2011
MEDLINE RETRACTABLE SAFETY SYRINGE
K101560 · Medline Industries, Inc. · Mar 2011
SAFE'N'SOUND PASSIVE DELIVERY SYSTEM
K101233 · Rexam Pharma · Feb 2011
ULTICARE SAFETY INSULIN SYRINGE
K103011 · Ulti-Med Intl., Inc. · Feb 2011
1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1
K100998 · Unilife Medical Solutions Limited · Aug 2010
MED-LOK
K093176 · Sta-Med, LLC · Apr 2010
K103781 · MED-LOK SAFETY NEEDLE
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