# K050821: Coagcare Anticoagulation Management System

- Pathway: 510(k) (Traditional)
- Applicant: Zycare
- Decided: Aug 16, 2005 after 138 days
- Product code: KQG (Instrument, Coagulation)
- Device class: 2
- Regulation: 21 CFR 864.5400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K882001 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882001: Diacare Monitoring System, Healthware Corp. (1988) Summary page 2.

## Indications for use
The CoagCare Anticoagulation Management System (CoagCare®) is an interactive, internet-based (web-based), rules-based expert software system for the long-term management of patients undergoing warfarin anticoagulation therapy. The system is an accessory to prescription home-use prothrombin time devices that measure International Normalized Ratios (INRs), and it facilitates remote clinical management between patient and caregiver. A caregiver may be a physician, nurse, pharmacist or licensed professional.

Source page: https://510kreport.com/device/K050821
Methodology: https://510kreport.com/methodology