# K014061: Simplicity Starplus Soft Infusion Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Sterling Medivations, Inc.
- Decided: Jan 17, 2002 after 38 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: 1 generation back to K010846 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010846: Simplicity Silver Set Soft Infusion, Sterling Medivations, Inc. (2001) Summary page 1.

## Indications for use
The intended use of the Simplicity StarPlus Soft Infusion Set is to provide a means for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe.

Source page: https://510kreport.com/device/K014061
Methodology: https://510kreport.com/methodology