# K081388: Glucocare Intensive Glycemic Control System

- Pathway: 510(k) (Traditional)
- Applicant: Pronia Medical System, LLC
- Decided: Aug 21, 2008 after 94 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: 8 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)
- K053137: Endotool Drug Dose Calculator, MD Scientific, LLC (2006) Summary page 1.
- K071713: Clarian Glucose Stabilizer Insulin Dosing Calculator, Medical Decisions Network (2007) Summary page 1.

## Indications for use
The GlucoCare IGC System is a software program indicated for the management of patient blood glucose levels in the hospital setting. The GlucoCare IGC System software, using an algorithm that is based on an established clinical protocol, calculates the dosage of intravenously administered insulin required to maintain the blood glucose level within a target range set by the protocol. No medical decisions are made by the GlucoCare IGC System software. The information provided by the software is intended to be used as a tool by qualified and trained medical personnel. The GlucoCare IGC System software is intended for use in patients over the age of 18 with no known insulin allergies. The device is not intended for use in patients with diabetic ketoacidosis.

Source page: https://510kreport.com/device/K081388
Methodology: https://510kreport.com/methodology