Cleared Traditional

COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM (K050821) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K050821 · Zycare · Hematology device
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Aug 2005
Decision
138d
Days
Class 2
Risk

K050821 is an FDA 510(k) clearance for the COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM. Classified as Instrument, Coagulation (product code KQG), Class II - Special Controls.

Submitted by Zycare (Chapel Hill, US). The FDA issued a Cleared decision on August 16, 2005 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5400 - 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.

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Submission Details

510(k) Number K050821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2005
Decision Date August 16, 2005
Days to Decision 138 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
25d slower than avg
Panel avg: 113d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KQG Instrument, Coagulation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5400
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.