# K071713: Clarian Glucose Stabilizer Insulin Dosing Calculator

- Pathway: 510(k) (Traditional)
- Applicant: Medical Decisions Network
- Decided: Oct 12, 2007 after 112 days
- Product code: NDC (Calculator, Drug Dose)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K941811 (1994). 33 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 36 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053137: Endotool Drug Dose Calculator, MD Scientific, LLC (2006) Summary page 1.
- K061110: Glucommander Plus, Collaborativemed, LLC (2006) Summary page 1.

## Most influential descendants
- K141321: Glucostabilizer Insulin Dosing Calculator (2014), 0 descendants of its own
- K081388: Glucocare Intensive Glycemic Control System (2008), 0 descendants of its own

## Indications for use
The MDN-CGSTM Insulin Dosing Calculator is intended to evaluate the current patient blood glucose values. Based on the measurements, the software will calculate either a dose of glucose or insulin to drive the blood glucose level up or down toward a predetermined target range. Once that target blood glucose range has been reached, the software program calculates dosing of insulin or glucose for the purpose of maintaining the patient's blood glucose level in that target range. The system is programmed to provide intravenous dosing calculations of glucose or insulin. The device is intended for use with patients with no known insulin allergies and for patients over the age of 18. The MDN-CGSTM Insulin Dosing Calculator programmed logic is a tool and not a substitute for, but rather an assist to, clinical reasoning. The measurements and calculations generated by the MDN-CGSTM Insulin Dosing Calculator are intended to be used by qualified and trained medical personnel directed by physician order. No medical decisions are to be made solely on the guidance provided by this software program, but are to include consideration of clinical history, symptoms, other diagnostic measurements, and the professional's clinical judgment.

Source page: https://510kreport.com/device/K071713
Methodology: https://510kreport.com/methodology