# K160673: Insulin Algorithms System

- Pathway: 510(k) (Traditional)
- Applicant: Insulin Algorithms
- Decided: Jun 7, 2017 after 454 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.
No later device cites it as a predicate yet.
1 of 37 devices in its family (counting itself) has a Class I recall.

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

## Indications for use
The Insulin Algorithms System (IA System) is a glycemic management software support program designed to provide insulin dosing recommendations to the clinician in order to adjust and maintain blood glucose levels in insulin-dependent diabetic patients within a clinician determined target range. The IA System evaluates a set of current and cumulative patient blood glucose values together with biometric information (including age, weight, height, and gender) and suggests changes (if necessary). The system is designed for use by healthcare professionals. The IA System is indicated for use in adults and pediatric patients ages 7 and above who weigh more than 36 lbs. The IA System is not intended to be used to provide insulin dosing recommendations to the clinician in order to adjust insulin treatment for patients hospitalized in an acute care setting. Also, the IA System is not intended to be used to provide insulin dosing recommendations for patients on insulin pump therapy or IV insulin therapy. Nor is IA System intended to provide recommendations for mealtime injections of insulin that are based on carb counting. The IA System is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software program.

Source page: https://510kreport.com/device/K160673
Methodology: https://510kreport.com/methodology