# K261461: Omnipod 6 algorithm

- Pathway: 510(k) (Traditional)
- Applicant: Insulet Corporation
- Decided: Jun 29, 2026 after 56 days
- Product code: QJI (Interoperable Automated Glycemic Controller)
- Device class: 2
- Regulation: 21 CFR 862.1356
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K220394 (2022). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251779: Omnipod 5 algorithm, Insulet Corporation (2025) Summary page 5.

## Indications for use
The Omnipod 6 algorithm is intended for use with compatible integrated continuous glucose monitors (ICGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and pause delivery of insulin based on current and predicted glucose values. The Omnipod 6 algorithm is intended for the management of type 1 diabetes mellitus in persons 2 years of age and older and type 2 diabetes mellitus in persons 18 years of age and older. The Omnipod 6 algorithm is intended for single patient use and requires a prescription.

Source page: https://510kreport.com/device/K261461
Methodology: https://510kreport.com/methodology