# K010846: Simplicity Silver Set Soft Infusion

- Pathway: 510(k) (Abbreviated)
- Applicant: Sterling Medivations, Inc.
- Decided: Apr 12, 2001 after 22 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K014061: Simplicity Starplus Soft Infusion Set (2002), 0 descendants of its own
- K013104: Simplicity QD Soft Infusion Set for Use by People with Diabetes in Infuse Insulin Subcutaneously From a Pump or Syringe (2001), 0 descendants of its own

Source page: https://510kreport.com/device/K010846
Methodology: https://510kreport.com/methodology