# K011580: Simplicity Soft QD Silver Infusion Set

- Pathway: 510(k) (Special)
- Applicant: Sterling Medivations, Inc.
- Decided: Jun 5, 2001 after 14 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 K010788 (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)
- K010788: Simplicity Soft QD Easy Infusion Set, Sterling Medivations, Inc. (2001) Summary page 1.

## Indications for use
The intended use is to provide a means to infuse or inject insulin subcutaneously when used with any infusion device that delivers continuous or intermittent flow.

Source page: https://510kreport.com/device/K011580
Methodology: https://510kreport.com/methodology