Cleared Traditional

K161316 - George King Coumadin Plasma

K161316 is the FDA 510(k) clearance for George King Coumadin Plasma by George King Bio-Medical, Inc.. It is a Class 2 Hematology device (product code GGN) cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K161316 · George King Bio-Medical, Inc. · Hematology device
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Feb 2017
Decision
288d
Days
Class 2
Risk

K161316 is an FDA 510(k) clearance for the George King Coumadin Plasma. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by George King Bio-Medical, Inc. (Overland Park, US). The FDA issued a Cleared decision on February 23, 2017 after a review of 288 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all George King Bio-Medical, Inc. devices

Submission Details

510(k) Number K161316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2016
Decision Date February 23, 2017
Days to Decision 288 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 113d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGN Plasma, Coagulation Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 Hematology devices follow this clearance model.

Regulatory Peers - GGN Plasma, Coagulation Control

All 47
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