# K251854: SteadiSet infusion set

- Pathway: 510(k) (Abbreviated)
- Applicant: Tandem Diabetes Care
- Decided: Aug 6, 2025 after 50 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). 8 ancestors in all.
No later device cites it as a predicate yet.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242692: SteadiSet Infusion Set, Capillary Biomedical, LLC (2025) Summary page 5.

## Indications for use
The SteadiSet infusion set is indicated for the subcutaneous infusion of insulin administered by an external pump. The infusion set is indicated for single use.

Source page: https://510kreport.com/device/K251854
Methodology: https://510kreport.com/methodology