Cleared Traditional

K062833 - POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM

K062833 is an FDA 510(k) clearance for POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM, manufactured by Vidacare Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FCF cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K062833 · Vidacare Corporation · Gastroenterology & Urology device
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Nov 2006
Decision
70d
Days
Class 2
Risk

K062833 is an FDA 510(k) clearance for the POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM. Classified as Instrument, Biopsy, Mechanical, Gastrointestinal (product code FCF), Class II - Special Controls.

Submitted by Vidacare Corporation (Irvine, US). The FDA issued a Cleared decision on November 30, 2006 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology 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 - K062833

510(k) Number K062833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2006
Decision Date November 30, 2006
Days to Decision 70 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 131d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCF Device Classification - Class 2, Special Controls

Product Code FCF Instrument, Biopsy, Mechanical, Gastrointestinal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FCF Instrument, Biopsy, Mechanical, Gastrointestinal

Devices cleared under the same product code (FCF) and FDA review panel - the closest regulatory comparables to K062833.
POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM
K070759 · Vidacare Corporation · May 2007
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K915142 · Intl. Medical, Inc. · Jan 1992
OVAL CUP BIOPSY FORCEP
K911155 · Endovations · Aug 1991
PHARMA-PLAST RECTAL TIP
K843477 · Zimmar Consulting , Ltd. · Dec 1984