Cleared Traditional

K092831 - DISPOSABLE HYPODERMIC NEEDLE

K092831 is an FDA 510(k) clearance for DISPOSABLE HYPODERMIC NEEDLE, manufactured by Feel Tech. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K092831 · Feel Tech · General Hospital
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Jan 2010
Decision
121d
Days
Class 2
Risk

K092831 is an FDA 510(k) clearance for the DISPOSABLE HYPODERMIC NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Feel Tech (Pittsburgh, US). The FDA issued a Cleared decision on January 14, 2010 after a review of 121 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 Feel Tech devices

FDA 510(k) Submission Details - K092831

510(k) Number K092831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2009
Decision Date January 14, 2010
Days to Decision 121 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
8d faster than avg
Panel avg: 129d · This submission: 121d
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 348
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K092831.
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K091140 · Vidacare Corporation · Oct 2009
K-PACK II NEEDLE - 29G THIN WALL
K082820 · Terumo Europe N.V. · Oct 2008
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K073188 · Smiths Medical Asd, Inc. · Feb 2008