Cleared Traditional

K102584 - IMC HYPODERMIC NEEDLE

K102584 is an FDA 510(k) clearance for IMC HYPODERMIC NEEDLE, manufactured by International Medsurg Connection. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K102584 · International Medsurg Connection · General Hospital
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Jan 2011
Decision
128d
Days
Class 2
Risk

K102584 is an FDA 510(k) clearance for the IMC HYPODERMIC NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by International Medsurg Connection (Schaumburg, US). The FDA issued a Cleared decision on January 14, 2011 after a review of 128 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 International Medsurg Connection devices

FDA 510(k) Submission Details - K102584

510(k) Number K102584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2010
Decision Date January 14, 2011
Days to Decision 128 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
1d faster than avg
Panel avg: 129d · This submission: 128d
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 264
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K102584.
BD AUTOSHIELD DUO PEN NEEDLE
K110703 · Becton, Dickinson and Company · Jul 2011
K-PACK II NEEDLE- 27G & 30G THIN WALL
K110850 · Terumo Europe N.V. · Jun 2011
K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE
K110527 · Terumo Europe N.V. · Jun 2011
BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY
K100209 · Becton, Dickinson & CO · Feb 2010
K-PACK II NEEDLE - 29G THIN WALL
K082820 · Terumo Europe N.V. · Oct 2008
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE
K073188 · Smiths Medical Asd, Inc. · Feb 2008