Cleared Traditional

K003381 - SHIELDING NEEDLE HOLDER

K003381 is an FDA 510(k) clearance for SHIELDING NEEDLE HOLDER, manufactured by U.S. Safety Syringes Co., Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K003381 · U.S. Safety Syringes Co., Inc. · General Hospital
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Apr 2001
Decision
174d
Days
Class 2
Risk

K003381 is an FDA 510(k) clearance for the SHIELDING NEEDLE HOLDER. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by U.S. Safety Syringes Co., Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on April 23, 2001 after a review of 174 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 U.S. Safety Syringes Co., Inc. devices

FDA 510(k) Submission Details - K003381

510(k) Number K003381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2000
Decision Date April 23, 2001
Days to Decision 174 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 129d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 350
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K003381.
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