Cleared Traditional

NOVOFINE 31 DISPOSABLE NEEDLE (K002403) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K002403 · Novo Norodisk Pharmaceuticals, Inc. · General Hospital
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Dec 2000
Decision
123d
Days
Class 2
Risk

K002403 is an FDA 510(k) clearance for the NOVOFINE 31 DISPOSABLE NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Novo Norodisk Pharmaceuticals, Inc. (Princeton, US). The FDA issued a Cleared decision on December 8, 2000 after a review of 123 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 Novo Norodisk Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K002403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2000
Decision Date December 08, 2000
Days to Decision 123 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
6d faster than avg
Panel avg: 129d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 183
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K002403.
BD ULTRA-FINE III PEN NEEDLE
K024109 · Becton, Dickinson & CO · Dec 2002
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BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
K003461 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 2001
B-D ULTRA-FINE III PEN NEEDLE
K002938 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 2000
LUER ACCESS UNIVERSAL VIAL ADAPTER
K000657 · Baxter Healthcare Corp · Mar 2000
BECTON DICKINSON BLUNT PLASTIC CANNULA
K974363 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998