# K163357: OneTouch Via On-Demand Insulin Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Lifescan Europe, A Division of Cilag GmbH
- Decided: Jun 7, 2017 after 189 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: 5 generations back to K031373 (2003). 7 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111924: Finesse Personal Insulin Delivery Patch, Calibra Medical, Inc. (2012) Summary page 4.

## Most influential descendants
- K233447: CeQur Simplicity™ On-Demand Insulin Delivery System (2024), 2 descendants of its own
- K243273: CeQur Simplicity™ On-Demand Insulin Delivery System (2024), 1 descendant of its own
- K252757: CeQur Simplicity™ On-Demand Insulin Delivery System (2026), 0 descendants of its own

## Indications for use
The One Touch Via™ 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/K163357
Methodology: https://510kreport.com/methodology