# K141321: Glucostabilizer Insulin Dosing Calculator

- Pathway: 510(k) (Traditional)
- Applicant: Medical Decision Network
- Decided: Sep 15, 2014 after 118 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: 9 generations back to K941811 (1994). 36 ancestors in all.
No later device cites it as a predicate yet.
1 of 37 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071713: Clarian Glucose Stabilizer Insulin Dosing Calculator, Medical Decisions Network (2007) Summary page 5.
- K113853: G+ System, Glytec, LLC (2012) Summary page 5.

## Indications for use
The GlucoStabilizer Insulin Dosing Calculator 3.0 is designed for use by order of a physician for hospitalized patients. It is intended to evaluate the current as well as cumulative patient blood glucose values, and based on those measurements, calculate and recommend a dose of insulin or dextrose to drive the blood glucose level either up or down towards a predetermined target range. Once that target blood glucose range has been reached, the system’s function is to recommend dosing of insulin or dextrose 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 insulin and dextrose for both adult and pediatric (ages 2 to <18 years) patients with no known insulin allergies. The GlucoStabilizer Insulin Dosing Calculator’s programmed logic is not a substitute for, but rather an assist to clinical reasoning. The measurements and calculations generated by the GlucoStabilizer Insulin Dosing Calculator are intended to be used by qualified and trained medical personnel in evaluating patient conditions in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional’s clinical judgment. No medical decisions should be based solely on the recommended guidance provided by this software program. Contraindications: The device is not intended for use with patients with known insulin allergies or patients under the age of 2 years. Warnings and Precautions: The GlucoStabilizer Insulin Dosing Calculator’s programmed logic is not a substitute for, but rather an assist to clinical reasoning. The measurements and calculations generated by the GlucoStabilizer Insulin Dosing Calculator are intended to be used by qualified and trained medical personnel in evaluating patient conditions in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional’s clinical judgment. No medical decisions should be based solely on the recommended guidance provided by this software program.

Source page: https://510kreport.com/device/K141321
Methodology: https://510kreport.com/methodology