Cleared Traditional

K032885 - VIDAPORT INTRAOSSEOUS INFUSION SYSTEM

K032885 is an FDA 510(k) clearance for VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, manufactured by Vidacare Corporation. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K032885 · Vidacare Corporation · General Hospital
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Mar 2004
Decision
176d
Days
Class 2
Risk

K032885 is an FDA 510(k) clearance for the VIDAPORT INTRAOSSEOUS INFUSION SYSTEM. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Vidacare Corporation (Irvine, US). The FDA issued a Cleared decision on March 10, 2004 after a review of 176 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 Vidacare Corporation devices

FDA 510(k) Submission Details - K032885

510(k) Number K032885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2003
Decision Date March 10, 2004
Days to Decision 176 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
47d slower than avg
Panel avg: 129d · This submission: 176d
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 264
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K032885.
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K033575 · B.Braun Medical, Inc. · Feb 2004
TERUMO SURGUARD 2 SAFETY NEEDLE
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MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE
K031200 · Becton, Dickinson & CO · Jun 2003