Cleared Traditional

K091140 - EZ-MIO DISTAL TIBIA

K091140 is an FDA 510(k) clearance for EZ-MIO DISTAL TIBIA, 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 177-day FDA review.

K091140 · Vidacare Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
177d
Days
Class 2
Risk

K091140 is an FDA 510(k) clearance for the EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTE.... 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 October 14, 2009 after a review of 177 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 - K091140

510(k) Number K091140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2009
Decision Date October 14, 2009
Days to Decision 177 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
48d slower than avg
Panel avg: 129d · This submission: 177d
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 K091140.
K-PACK II NEEDLE- 27G & 30G THIN WALL
K110850 · Terumo Europe N.V. · Jun 2011
K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE
K110527 · Terumo Europe N.V. · Jun 2011
BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY
K100209 · Becton, Dickinson & CO · Feb 2010
K-PACK II NEEDLE - 29G THIN WALL
K082820 · Terumo Europe N.V. · Oct 2008
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE
K073188 · Smiths Medical Asd, Inc. · Feb 2008
STERICAN HYPODERMIC NEEDLES
K072247 · B.Braun Medical, Inc. · Nov 2007