# K252757: CeQur Simplicity™ On-Demand Insulin Delivery System

- Pathway: 510(k) (Special)
- Applicant: Cequr SA
- Decided: Apr 10, 2026 after 224 days
- Product code: OPP (Pump, Infusion, Insulin Bolus)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K031373 (2003). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243273: CeQur Simplicity™ On-Demand Insulin Delivery System, Cequr SA (2024) Summary page 5.
- K233447: CeQur Simplicity™ On-Demand Insulin Delivery System, Cequr SA (2024) Summary page 5.
- K163357: OneTouch Via On-Demand Insulin Delivery System, Lifescan Europe, A Division of Cilag GmbH (2017) Summary page 5.

## Indications for use
The CeQur Simplicity™ On-Demand Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.

Source page: https://510kreport.com/device/K252757
Methodology: https://510kreport.com/methodology