# K132547: Endo Tool Glucose Management System (Egms)

- Pathway: 510(k) (Abbreviated)
- Applicant: Monarch Medical Technologies
- Decided: Apr 17, 2014 after 247 days
- Product code: NDC (Calculator, Drug Dose)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K941811 (1994). 35 ancestors in all.
8 later devices descend from it; 3 cite it directly.
1 of 44 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113853: G+ System, Glytec, LLC (2012) Summary page 1.
- K053137: Endotool Drug Dose Calculator, MD Scientific, LLC (2006) Summary page 1.

## Most influential descendants
- 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
- K241088: EndoTool IV (3.1) (2024), 1 descendant of its own
- K180366: EndoTool SubQ (2018), 1 descendant of its own

## Recalls of this device
- May 3, 2019 · Class II · Z-1786-2019: Insulin dosing calculations were erroneously high.

## Indications for use
By evaluating current and cumulative blood glucose levels, the Endo-rool Glucose Management Sysstem (EGMS) - a glycemic management software support program is designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as dextrose, to adjust and maintain the blood glucose level within a configurable clinician-determined target range. The EndoTool Drug Delivery Calculator is indicated for use in adult and pediatric patients ages 2 years and above and who weigh 12 kgs. or more. The EGMS 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/K132547
Methodology: https://510kreport.com/methodology