# K254102: Glucommander

- Pathway: 510(k) (Traditional)
- Applicant: Glytec, LLC
- Decided: May 27, 2026 after 159 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: 10 generations back to K941811 (1994). 34 ancestors in all.
No later device cites it as a predicate yet.
1 of 35 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152300: Glucommander, Glytec, LLC (2017) Summary page 6.

## Indications for use
Glucommander is a glycemic management tool intended to evaluate current as well as cumulative patient blood glucose values coupled with patient information including age, weight and height, and, based on the aggregate of these measurement parameters, whether one or many, recommend an IV dosage of insulin, glucose or saline or a subcutaneous basal and bolus insulin dosing recommendation to adjust and maintain the blood glucose level towards a configurable physician-determined target range. Glucommander is indicated for use in adult and pediatric (ages 2 - 17 years) patients. The measurements and calculations generated 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. Glucommander logic is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software program.

Source page: https://510kreport.com/device/K254102
Methodology: https://510kreport.com/methodology