Cleared Traditional

K002403 - NOVOFINE 31 DISPOSABLE NEEDLE

K002403 is an FDA 510(k) clearance for NOVOFINE 31 DISPOSABLE NEEDLE, manufactured by Novo Norodisk Pharmaceuticals, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K002403 · Novo Norodisk Pharmaceuticals, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K002403

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
Combination Product No
PCCP Authorized No
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.

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 693
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K002403.
GUARDED NEEDLE 2000
K003406 · International Medical Device Partners, Inc. · Jan 2001
PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION
K003827 · Bio-Plexus, Inc. · Jan 2001
VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET
K000714 · Med-Pro Technologies, Inc. · Dec 2000
B-D ULTRA-FINE III PEN NEEDLE
K002938 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 2000
SIMPLICITY DISPOSABLE PEN NEEDLE
K002180 · Sterling Medivations, Inc. · Oct 2000
BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID
K002213 · Hunter Research Laboratories, Inc. · Oct 2000
K002403 · NOVOFINE 31 DISPOSABLE NEEDLE
Download PDF FDA Summary Novo Norodisk Pharmac…