# K261530: iiSure Infusion Set

- Pathway: 510(k) (Special)
- Applicant: Deka Research and Development
- Decided: Jun 3, 2026 after 26 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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 K972135 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243841: Sparta Infusion Set for Insulin, Deka Research and Development (2025) Summary page 5.

## Indications for use
The iiSure Infusion Set is indicated for the subcutaneous infusion of insulin, administered by an external pump. The infusion set is indicated for use with adult and pediatric users weighing greater than 10 kg. The infusion set is indicated for single-use.

Source page: https://510kreport.com/device/K261530
Methodology: https://510kreport.com/methodology