# K260910: EndoTool IV Cloud 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Glooko, Inc.
- Decided: May 1, 2026 after 43 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: 13 generations back to K941811 (1994). 39 ancestors in all.
No later device cites it as a predicate yet.
1 of 40 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241088: EndoTool IV (3.1), Monarch Medical Technologies (2024) Summary page 5.

## Indications for use
EndoTool Cloud is intended for use by trained healthcare professionals in inpatient care settings to assist in the management of blood glucose levels in adult and pediatric patients aged two years and older who weigh at least 12 kg. The software is intended to recommend patient-specific intravenous insulin dosing, carbohydrate dosing for recovery of or supplementation, and subcutaneous insulin dosing for the transition from intravenous therapy and for ongoing management of hyperglycemia. EndoTool Cloud generates dosing recommendations based on the prescribing healthcare provider’s orders for target glucose range, dosing mode and patient-specific clinical characteristics. The software is intended to assist healthcare professionals in adjusting and maintaining a patient’s glucose level within a configurable, clinician-determined target range. The EndoTool Cloud logic is not a substitute for clinical judgment but is intended as a decision support tool for trained healthcare professionals. Final dose decisions must be made by the healthcare professional after consideration of the patient’s overall clinical status. No medical decision should be made solely based on the recommendations provided by this software.

Source page: https://510kreport.com/device/K260910
Methodology: https://510kreport.com/methodology