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EndoTool SubQ

FDA 510(k)

Class II (US FDA 510(k))

510(k) K142918

by Monarch Medical Technologies

Identifiers

510(k) Number
K142918 FDA 510(k)
FDA Product Code
NDC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1890 FDA 510(k)
Regulation Number
868.1890 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

EndoTool SubQ is a software application designed to aid healthcare professionals in calculating and suggesting individualised insulin dosages for patients with Diabetes Mellitus. It is a patient-specific insulin dosing system that simplifies the complex task of glycemic management in hospital environments.

EndoTool SubQ is supplied as a software application for use by healthcare professionals in hospital settings. It has received FDA 510(k) clearance (K142918) and is classified as a Class II device under regulation number 868.1890, with product code NDC and medical specialty in Anesthesiology.

Frequently asked questions

What is the EndoTool SubQ device intended for?

EndoTool SubQ is a software application designed to aid healthcare professionals in calculating and suggesting individualised insulin dosages for patients with Diabetes Mellitus, simplifying glycemic management in hospital environments.

How is the EndoTool SubQ SubQ supplied and used?

EndoTool SubQ is supplied as a software application for use by healthcare professionals in hospital settings, requiring no physical components for operation beyond compatible computing systems.

What regulatory pathway was used for EndoTool SubQ?

EndoTool SubQ received FDA 510(k) clearance under submission K142918, indicating it was found substantially equivalent to a legally marketed predicate device.

What is the classification and regulation number for EndoTool SubQ?

EndoTool SubQ is classified as a Class II medical device under regulation number 868.1890, with product code NDC and medical specialty in Anesthesiology.

Who manufactures EndoTool SubQ and where are they located?

EndoTool SubQ is manufactured by Monarch Medical Technologies, located at 2137 S. Blvd., Suite 300, Charlotte, NC 28203, United States.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EndoTool® Patient-Specific Insulin Dosing System | Monarch Medical ..., Monarch Medical Technologies, a Glooko Company | EndoTool® Patient ..., Monarch Medical Technologies EndoTool SubQ User Guide, EndoTool SubQ Review: Pricing, FDA Status & Alternatives | Physician AI ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Monarch Medical Technologies

Sources (1)

  • FDA 510(k) K142918 24 fields · synced Sep 19, 2026