Cleared Traditional

K051762 - SAF-T-SYRINGE/SAF-T-NEEDLE

K051762 is an FDA 510(k) clearance for SAF-T-SYRINGE/SAF-T-NEEDLE, manufactured by Safety Medical International, Incorporated. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K051762 · Safety Medical International, Incorporated · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
85d
Days
Class 2
Risk

K051762 is an FDA 510(k) clearance for the SAF-T-SYRINGE/SAF-T-NEEDLE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Safety Medical International, Incorporated (Apopka, US). The FDA issued a Cleared decision on September 23, 2005 after a review of 85 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Safety Medical International, Incorporated devices

FDA 510(k) Submission Details - K051762

510(k) Number K051762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2005
Decision Date September 23, 2005
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
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 56
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K051762.
PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
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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
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K993609 · Safeguard Medical Products, Inc. · Mar 2000