# K053137: Endotool Drug Dose Calculator

- Pathway: 510(k) (Traditional)
- Applicant: MD Scientific, LLC
- Decided: Jun 14, 2006 after 217 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: 1 generation back to K011571 (2001). 1 ancestor in all.
12 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011571: TRXF Intelligent Dosing System (Ids) -Dosing Calculator Suite, The RX Files Corp. (2001)

## Most influential descendants
- 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
- K071713: Clarian Glucose Stabilizer Insulin Dosing Calculator (2007), 2 descendants of its own

## Indications for use
The EndoTooliM Drug Dose Calculator is a software support system designed for use by trained healthcare professionals to calculate any individual patient's optimal next dose for insulin administered intravenously to control blood glucose level for critically ill patients without inducing hypoglycemia (low blood glucose levels). EndoToolTM is for use with patients who are receiving a relative constant nutritional intake via intravenous fluids with dextrose, total parental nutrition or continuous gastro-intestinal feedings by any route of delivery.

Source page: https://510kreport.com/device/K053137
Methodology: https://510kreport.com/methodology