# K230545: Inessa System

- Pathway: 510(k) (Traditional)
- Applicant: Triple Jump Israel, Ltd.
- Decided: Dec 20, 2023 after 295 days
- Product code: QFG (Alternate Controller Enabled Insulin Infusion Pump)
- Device class: 2
- Regulation: 21 CFR 880.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN180058 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191679: Omnipod DASH Insulin Management System with interoperable technology, Insulet Corporation (2019) Summary page 4.

## Indications for use
The Inessa System is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Inessa System is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The Inessa System is intended for single patient, home use and requires a prescription. The Inessa System is indicated for use in individuals 6 years of age and greater.

Source page: https://510kreport.com/device/K230545
Methodology: https://510kreport.com/methodology