Cleared Traditional

K052195 - EZ-MIO MANUAL DRIVER

K052195 is an FDA 510(k) clearance for EZ-MIO MANUAL DRIVER, 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 83-day FDA review.

K052195 · Vidacare Corporation · General Hospital
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Nov 2005
Decision
83d
Days
Class 2
Risk

K052195 is an FDA 510(k) clearance for the EZ-MIO MANUAL DRIVER. 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 November 2, 2005 after a review of 83 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 Vidacare Corporation devices

FDA 510(k) Submission Details - K052195

510(k) Number K052195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2005
Decision Date November 02, 2005
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
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 500
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K052195.
TERUMO MICRO TAPERED PEN NEEDLE
K052561 · Kofu Factory of Terumo Corp. · Nov 2005
EZ-IO
K052408 · Vidacare Corporation · Nov 2005
NIPRO HYPODERMIC NEEDLE
K052474 · Nipro Medical Corp. · Nov 2005
POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM
K051992 · Vidacare Corporation · Oct 2005
ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES
K051783 · Artsana S.P.A · Oct 2005
BD PEN NEEDLE
K051899 · Becton, Dickinson & CO · Sep 2005