Cleared Traditional

K093109 - NOVOTWIST NEEDLE

K093109 is an FDA 510(k) clearance for NOVOTWIST NEEDLE, manufactured by Novo Nordisk, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K093109 · Novo Nordisk, Inc. · General Hospital
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Jun 2010
Decision
260d
Days
Class 2
Risk

K093109 is an FDA 510(k) clearance for the NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5'). Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Novo Nordisk, Inc. (Princeton, US). The FDA issued a Cleared decision on June 18, 2010 after a review of 260 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 Novo Nordisk, Inc. devices

FDA 510(k) Submission Details - K093109

510(k) Number K093109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2009
Decision Date June 18, 2010
Days to Decision 260 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
131d slower than avg
Panel avg: 129d · This submission: 260d
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 275
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K093109.
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