# K142918: EndoTool SubQ

- Pathway: 510(k) (Traditional)
- Applicant: Monarch Medical Technologies
- Decided: Apr 24, 2015 after 199 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: 10 generations back to K941811 (1994). 36 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 39 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132547: Endo Tool Glucose Management System (Egms), Monarch Medical Technologies (2014) Summary page 4.
- K113853: G+ System, Glytec, LLC (2012) Summary page 4.

## Most influential descendants
- K180366: EndoTool SubQ (2018), 1 descendant of its own
- K211160: EndoTool SubQ 2.1 (2021), 0 descendants of its own

## Indications for use
EndoTool SubQ is a software application for use by trained healthcare professionals to calculate and recommend an individual patient’s next dose of insulin to be administered subcutaneously to manage blood glucose levels in patients with Diabetes Mellitus in both adult and pediatric patients (age 2 years and above and 12 kg or more). The software is designed to recommend the insulin dose(s) (and when indicated a carbohydrate dose) based on the prescribing healthcare provider’s nutritional regimen, insulin regimen, target glucose range, and patient specific characteristics. The EndoTool SubQ is not a substitute for clinical reasoning, but is an aid for trained healthcare professionals to manage patients. The System is based on obtained glucose readings and clinical data entered by the medical staff. Final dose decisions for a patient must be made only after consideration of the full clinical status of the patient. No medical decision should be made based solely on the recommendations provided by this software program.

Source page: https://510kreport.com/device/K142918
Methodology: https://510kreport.com/methodology