Cleared Traditional

K051783 - ARTSANA PEN NEEDLES

K051783 is an FDA 510(k) clearance for ARTSANA PEN NEEDLES, manufactured by Artsana S.P.A. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K051783 · Artsana S.P.A · General Hospital
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Oct 2005
Decision
95d
Days
Class 2
Risk

K051783 is an FDA 510(k) clearance for the ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Artsana S.P.A (Bristol, US). The FDA issued a Cleared decision on October 4, 2005 after a review of 95 days - within the typical 510(k) review window.

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 Artsana S.P.A devices

FDA 510(k) Submission Details - K051783

510(k) Number K051783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2005
Decision Date October 04, 2005
Days to Decision 95 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
34d faster than avg
Panel avg: 129d · This submission: 95d
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 305
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K051783.
NIPRO HYPODERMIC NEEDLE
K052474 · Nipro Medical Corp. · Nov 2005
EZ-MIO MANUAL DRIVER
K052195 · Vidacare Corporation · Nov 2005
POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM
K051992 · Vidacare Corporation · Oct 2005
BD PEN NEEDLE
K051899 · Becton, Dickinson & CO · Sep 2005
PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE
K043490 · Vidacare Corporation · Feb 2005
MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE
K043397 · Becton, Dickinson & CO · Dec 2004