# K020912: Simplicity Easy Soft Infusion Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Sterling Medivations, Inc.
- Decided: Apr 10, 2002 after 21 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: 2 generations back to K972135 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014062: Simplicity Easy Access Infusion Set, Sterling Medivations, Inc. (2002) Summary page 1.

## Most influential descendants
- K021530: Simplicity Easy P Soft Infusion Set for Infusion and/or Injection of Fluids Into the Body Below the Surface of the Skin (2002), 0 descendants of its own

## Indications for use
The intended use of the Simplicity Easy 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/K020912
Methodology: https://510kreport.com/methodology