# K020629: Simplicity Simplex Soft Infusion Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Sterling Medivations, Inc.
- Decided: Apr 1, 2002 after 34 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
- K021216: Simplicty Simplex P Infusion Set for Use with the Minimed Paradigm Infusion Pumps (2002), 0 descendants of its own

## Indications for use
The intended use of the Simplicity Simplex 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/K020629
Methodology: https://510kreport.com/methodology