Cleared Traditional

K052445 - DUOPROSS NEEDLE

K052445 is an FDA 510(k) clearance for DUOPROSS NEEDLE, manufactured by Duopross Meditech Corporation. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K052445 · Duopross Meditech Corporation · General Hospital
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Dec 2005
Decision
89d
Days
Class 2
Risk

K052445 is an FDA 510(k) clearance for the DUOPROSS NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Duopross Meditech Corporation (Albuquerque, US). The FDA issued a Cleared decision on December 5, 2005 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Duopross Meditech Corporation devices

FDA 510(k) Submission Details - K052445

510(k) Number K052445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2005
Decision Date December 05, 2005
Days to Decision 89 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
40d faster than avg
Panel avg: 129d · This submission: 89d
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 391
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K052445.
29G AND 30G K-PACK II NEEDLE
K062608 · Terumo Europe N.V. · Sep 2006
BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE
K052843 · Busse Hospital Disposables, Inc. · Apr 2006
BD AUTOSHIELD PEN NEEDLE
K060007 · Becton, Dickinson & CO · Mar 2006
EZ-IO
K052408 · Vidacare Corporation · Nov 2005
NIPRO HYPODERMIC NEEDLE
K052474 · Nipro Medical Corp. · Nov 2005
EZ-MIO MANUAL DRIVER
K052195 · Vidacare Corporation · Nov 2005