# K020990: Simplicity Soft QD II Infusion Set for Infusion and/or Injection of Fluids Into the Body Below the Surface of the Skin

- Pathway: 510(k) (Special)
- Applicant: Sterling Medivations, Inc.
- Decided: Apr 10, 2002 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K021296: Simplicity QD Easy P Infusion Set (2002), 0 descendants of its own

## 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/K020990
Methodology: https://510kreport.com/methodology