Cleared Traditional

K120247 - EASYDEX

K120247 is an FDA 510(k) clearance for EASYDEX, manufactured by Vineland Syrup, Inc.. The device is a Class 2 Chemistry device with product code MRV cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K120247 · Vineland Syrup, Inc. · Chemistry device
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Jun 2012
Decision
146d
Days
Class 2
Risk

K120247 is an FDA 510(k) clearance for the EASYDEX. Classified as Drink, Glucose Tolerance (product code MRV), Class II - Special Controls.

Submitted by Vineland Syrup, Inc. (Sewell, US). The FDA issued a Cleared decision on June 21, 2012 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Vineland Syrup, Inc. devices

FDA 510(k) Submission Details - K120247

510(k) Number K120247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2012
Decision Date June 21, 2012
Days to Decision 146 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 88d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRV Device Classification - Class 2, Special Controls

Product Code MRV Drink, Glucose Tolerance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 Chemistry devices follow this clearance model.