# K234027: embecta Insulin Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Embecta Medical I, LLC
- Decided: Aug 30, 2024 after 254 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 5.

## Indications for use
The embecta Insulin Delivery System with interoperable technology (the Patch) is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin, for individuals 18 years of age and older. The Patch 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 patch is intended for single patient, home use and requires a prescription.

Source page: https://510kreport.com/device/K234027
Methodology: https://510kreport.com/methodology