510(k) Report

510(k) · Cleared

Cleared

Coagcare Anticoagulation Management System

K050821510(k) TraditionalCleared Aug 16, 2005138-day reviewClass II21 CFR 864.5400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Zycare · KQG Instrument, Coagulation

Cleared on Aug 16, 2005 as substantially equivalent to K882001 (Healthware Corp., 1988) after a 138-day review. Its family tree reaches back 1 generation to 1988.

Decided
Aug 16, 2005
Review
138 days
Class
Class II
Product code
KQG
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K882001 (1988). No later device cites it as a predicate yet.

K882001 · Diacare Monitoring System · Healthware Corp. · 198819851990199520002005
K882001 · Diacare Monitoring System · Healthware Corp. · 19880
  1. Root · 1 generation backK882001 Diacare Monitoring SystemHealthware Corp. · 1988
  2. This deviceK050821 Coagcare Anticoagulation Management SystemZycare · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K882001Diacare Monitoring SystemHealthware Corp.1988—
0 (this device)K050821Coagcare Anticoagulation Management SystemZycare2005—
FIG. 1 — Lineage of K050821, 1988–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K882001Diacare Monitoring System
Summary page 2
…arketed predicate device The CoagCare® Anticoagulation Management System is substantially equivalent to the Diacare® Monitoring System, K882001, cleared October 18, 1988; the Diacare system was cleared for the clinical management of diabetes mellitus.…
Healthware Corp.1988—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All KQG devices

KQG Instrument, Coagulation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KQG

FDA has decided no KQG device since 2007.

Median 510(k) review, days · KQG

Too few KQG 510(k)s in any year since 2007 to give a median.

Recalls per year · KQG

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KQG

16in 2010

2009: 82010: 16
2007high 16 (2010) · low 0 (2007)2025

MAUDE reports naming product code KQG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—08
20100—116
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

Recent decisions in KQG

The KQG category page

  • K021976Fibron-1, Fibron-4, Quikcoag, FibronVital Scientific N.V. · 2002
  • K992130Pacific Hemostasis Thromboscreen 400CPacific Hemostasis · 1999
  • K991321Pacific Hemostasis Thromboscreen 200Pacific Hemostasis · 1999
  • K983475Hemochron ResponseInternational Technidyne Corp. · 19991 recall
  • K902614Elvi 828 Digiclot MultiscanLogos Scientific, Inc. · 1990

https://510kreport.com/device/K050821 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050821: Coagcare Anticoagulation Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050821

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026