Cleared Traditional

K050821 - COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM

K050821 is an FDA 510(k) clearance for COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM, manufactured by Zycare. The device is a Class 2 Hematology device with product code KQG cleared through the Traditional 510(k) pathway after a 138-day FDA review.

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.

View all Zycare devices

FDA 510(k) Submission Details - K050821

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
Combination Product No
PCCP Authorized No
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.

KQG Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KQG Instrument, Coagulation

All 7
Devices cleared under the same product code (KQG) and FDA review panel - the closest regulatory comparables to K050821.
PACIFIC HEMOSTASIS THROMBOSCREEN 400C
K992130 · Pacific Hemostasis · Sep 1999
PACIFIC HEMOSTASIS THROMBOSCREEN 200
K991321 · Pacific Hemostasis · Jun 1999
HEMOCHRON RESPONSE
K983475 · International Technidyne Corp. · May 1999
ELECTRA 800 AUTOMATIC COAGULATION TIMER
K851169 · Medical Laboratory Automation Systems, Inc. · Jun 1985
KOAGULAB 40-A AUTOMATED COAGULATION SYS
K823131 · Ortho Diagnostic Systems, Inc. · Dec 1982
ELVI BICLOT 816
K812906 · Volu Sol Medical Industries · Jul 1982