# K180366: EndoTool SubQ

- Pathway: 510(k) (Traditional)
- Applicant: Al Pacheco and Associates
- Decided: Sep 20, 2018 after 220 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: 11 generations back to K941811 (1994). 37 ancestors in all.
1 later device descends 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)
- K142918: EndoTool SubQ, Monarch Medical Technologies (2015) Summary page 4.

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

## Indications for use
EndoTool SubQ is a software management system for use by trained healthcare professionals to calculate and recommend an individual patient’s next dose of insulin to be administered subcutaneously to manage elevated blood glucose levels in both adult and pediatric patients (age 2 and above and 12 kg or more). The software is designed to recommend the insulin dose(s) (and on occasion a carbohydrate dose for the treatment of hypoglycemia) based on the prescribing healthcare provider’s insulin regimen, target glucose level range, and nutritional regimen. The software provides an optional insulin-on-board (IOB) calculation that estimates the sum of the remaining insulin activity from previously administered subcutaneous insulin(s). This IOB adjustment reduces the prescribed Bolus dose and, if appropriate, recommends a supplemental carbohydrate dose to the trained healthcare professional. EndoTool SubQ is not a substitute for clinical reasoning, but rather an aid for trained healthcare professionals based on timely, accurately obtained glucose readings and timely, accurately entered clinical data. Final dose recommendations for a patient must be accepted only after consideration of the full clinical status of the patient. No medical decision should be made based solely upon the recommendations provided by this software program.

Source page: https://510kreport.com/device/K180366
Methodology: https://510kreport.com/methodology