# K241088: EndoTool IV (3.1)

- Pathway: 510(k) (Traditional)
- Applicant: Monarch Medical Technologies
- Decided: Dec 11, 2024 after 236 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: 12 generations back to K941811 (1994). 38 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 40 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201619: EndoTool IV System, Monarch Medical Technologies, LLC (2020) Summary page 5.

## Most influential descendants
- K260910: EndoTool IV Cloud 1.0 (2026), 0 descendants of its own

## Indications for use
EndoTool IV 3.1 is a glucose management software system used by healthcare professionals in all inpatient care settings for adult and pediatric patients aged two years and above who weigh 12 kgs. or more. EndoTool adjusts and maintains a patient’s glucose level within a configurable clinician-determined target range by recommending patient-specific intravenous insulin dosing, carbohydrate dosing for recovery or supplementation, and subcutaneous dosing for the transition from IV dosing. EndoTool IV 3.1 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 system.

Source page: https://510kreport.com/device/K241088
Methodology: https://510kreport.com/methodology