Cleared Traditional

K113505 - VACUETTE QUICKSHIELD WITH SNAPPY TUBE H...

K113505 is an FDA 510(k) clearance for VACUETTE QUICKSHIELD WITH SNAPPY TUBE H..., manufactured by Greiner Bio-One North America, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K113505 · Greiner Bio-One North America, Inc. · General Hospital
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Feb 2012
Decision
81d
Days
Class 2
Risk

K113505 is an FDA 510(k) clearance for the VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Greiner Bio-One North America, Inc. (Baldwin, US). The FDA issued a Cleared decision on February 17, 2012 after a review of 81 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 Greiner Bio-One North America, Inc. devices

FDA 510(k) Submission Details - K113505

510(k) Number K113505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2011
Decision Date February 17, 2012
Days to Decision 81 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 faster than avg
Panel avg: 129d · This submission: 81d
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 272
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