510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050821Substantially Equivalent

Coagcare Anticoagulation Management System

Zycare, Chapel Hill NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050821 is the FDA 510(k) clearance record for COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM, a class II device, cleared for Zycare on under FDA product code KQG (Instrument, Coagulation). FDA records list one 510(k) clearance for Zycare. As of , FDA records show no recalls naming K050821.

Clearance record

Decision date
Received
(138 days to decision)
Product code
KQG Instrument, Coagulation
Regulation
21 CFR 864.5400
Device class
Class II
Review panel
Hematology
Applicant
Zycare 3804 Sweeten Creek Rd., Chapel Hill NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KQG

Trailing 12 months

FDA records hold no clearances under product code KQG in the trailing twelve months.

FDA records show no clearances under product code KQG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KQG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260