# K011187: Simplicity Soft YP Infusion Set for Use with the Minimed Paragigm Infusion Pumps

- Pathway: 510(k) (Abbreviated)
- Applicant: Sterling Medivations, Inc.
- Decided: Jun 19, 2001 after 62 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.
4 later devices descend from it; 4 cite it directly.
0 of 5 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
- 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
- K021487: Simplicity Easy Access P Infusion Set (2002), 0 descendants of its own
- K021296: Simplicity QD Easy P Infusion Set (2002), 0 descendants of its own
- K021216: Simplicty Simplex P Infusion Set for Use with the Minimed Paradigm Infusion Pumps (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K011187
Methodology: https://510kreport.com/methodology