# K232741: SmartAdjust (TM) technology

- Pathway: 510(k) (Traditional)
- Applicant: Insulet Corporation
- Decided: May 29, 2024 after 265 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: 1 generation back to K220394 (2022). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220394: SmartAdjust (TM) technology, Insulet Corporation (2022) Summary page 4.

## Most influential descendants
- K241777: SmartAdjust™ Technology (2024), 2 descendants of its own
- K251779: Omnipod 5 algorithm (2025), 1 descendant of its own
- K261461: Omnipod 6 algorithm (2026), 0 descendants of its own

## Indications for use
SmartAdjust™ technology 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. SmartAdjust™ technology is intended for the management of type 1 diabetes mellitus in persons 2 years of age and older. SmartAdjust™ technology is intended for single patient use and requires a prescription.

Source page: https://510kreport.com/device/K232741
Methodology: https://510kreport.com/methodology