# K101344: G+ System

- Pathway: 510(k) (Special)
- Applicant: Glytec, LLC (Formally Known AS Glucotec, Inc.)
- Decided: Jun 28, 2010 after 46 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). 31 ancestors in all.
13 later devices descend from it; 1 cites it directly.
1 of 45 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061110: Glucommander Plus, Collaborativemed, LLC (2006) Summary page 1.

## Most influential descendants
- K113853: G+ System (2012), 12 descendants of its own
- K132547: Endo Tool Glucose Management System (Egms) (2014), 8 descendants of its own
- K200443: EndoTool IV 1.10 (2020), 3 descendants of its own
- K201619: EndoTool IV System (2020), 2 descendants of its own
- K142918: EndoTool SubQ (2015), 2 descendants of its own

## Indications for use
The Glucommander is intended to evaluate the current as well as cumulative patient blood glucose values, and, based on the aggregate of those measurements, whether one or many, calculate and recommend a dose of saline, glucose, and insulin 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, glucose, and saline for the purpose of maintaining the patient's blood glucose level in that target range. The system is programmed to provide intravenous dosing of glucose, saline, and insulin; as well as subcutaneous dosing of glucose and insulin. The device is not intended for use with patients with known insulin allergies or patients under the age of 18. The Glucommander's programmed logic is not a substitute for, but rather an assist to clinical reasoning. The measurements and calculations generated by the GBGDS 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 decision should be based solely on he recommended guidance provided by this software program.

Source page: https://510kreport.com/device/K101344
Methodology: https://510kreport.com/methodology