# K161865: iSage Rx (iSage Rx Basal Insulin Titration)

- Pathway: 510(k) (Traditional)
- Applicant: Isag Rx, Inc.
- Decided: Mar 7, 2017 after 243 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K242066: iSage Rx (2024), 0 descendants of its own

## Indications for use
iSage Rx™ (iSage Rx Basal Insulin Titration) is software indicated for use by adult patients aged 21 and above who have type 2 diabetes and their healthcare providers to titrate basal insulin. iSage Rx is not intended to replace the care and management provided by a healthcare professional trained in the management of diabetes. iSage Rx should not be used by patients with type 2 diabetes who are also using prandial insulin or patients with type 1 diabetes, gestational diabetes, or patients using an insulin pump.

Source page: https://510kreport.com/device/K161865
Methodology: https://510kreport.com/methodology