EndoTool SubQ

FDA 510(k) K142918 · Monarch Medical Technologies

Substantially Equivalent

510(k) numberK142918

Submission

Device name
EndoTool SubQ
Applicant
Monarch Medical Technologies
Charlotte, NC, US
Received
October 7, 2014
Decision date
April 24, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NDC – Calculator, Drug Dose
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1890
Specialty
Anesthesiology

Other 510(k)s with product code NDC

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K254102GlucommanderNDC · Traditional Glytec, LLC05/27/2026SE
K260910EndoTool IV Cloud 1.0NDC · Traditional Glooko, Inc.05/01/2026SE
K253512MiniMed Go AppNDC · Traditional Medtronic Minimed01/08/2026SE
K253281UpDocNDC · Traditional Updoc, Inc.12/23/2025SE
K252104T1D1NDC · Traditional Comerge AG08/20/2025SE
K241088EndoTool IV (3.1)NDC · Traditional Monarch Medical Technologies12/11/2024SE
K242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))NDC · Traditional Medtronic Minimed11/12/2024SE
K242066iSage RxNDC · Traditional Amalgam Rx, Inc.08/21/2024SE
K232451Insulia Bolus CompanionNDC · Traditional Voluntis Sa.12/12/2023SE
K230813BlueStar and BlueStar RxNDC · Traditional Welldoc, Inc.07/28/2023SE

More from Welldoc, Inc.

510(k)DeviceDecision
K241088EndoTool IV (3.1)NDC · Traditional 12/11/2024SE
K211160EndoTool SubQ 2.1NDC · Traditional 10/28/2021SE
K201619EndoTool IV SystemNDC · Traditional 08/07/2020SE
K200443EndoTool IV 1.10NDC · Traditional 03/17/2020SE
K132547Endo Tool Glucose Management System (Egms)NDC · Abbreviated 04/17/2014SE

Questions and answers

When was EndoTool SubQ cleared by the FDA?

EndoTool SubQ (K142918) received a 510(k) decision of Substantially Equivalent on April 24, 2015, 199 days after the submission was received.

What is the product code of K142918?

The FDA product code is NDC – Calculator, Drug Dose, a Class II (moderate risk) device regulated under 21 CFR 868.1890.