# K020530: Evans Sub-Q, Model MC4206

- Pathway: 510(k) (Traditional)
- Applicant: Evans Medical, Inc.
- Decided: Apr 29, 2002 after 69 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 K831445 (1983). 3 ancestors in all.
17 later devices descend from it; 6 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961474: Polyfin Infusion Set MMT-106/MMT-107/MMT-133, Medtronic Minimed (1996) Summary page 1.

## Most influential descendants
- K140131: Sub-Q Subcutaneous Tissue Infusion Set (2014), 8 descendants of its own
- K142319: SCIg60 Infuser, Infuset (2015), 6 descendants of its own
- K082818: Subcutaneous Needle Infusion Set (2008), 6 descendants of its own
- K161906: SCIg60 Infuser (2016), 5 descendants of its own
- K222087: SCIg60 Infusion System (2022), 3 descendants of its own

## Indications for use
“Evans Sub-Q” (Catalog # MC4206) Winged Subcutaneous Tissue Infusion Set is intended to provide subcutaneous infusion of medicine from an external infusion pump or syringe.

Source page: https://510kreport.com/device/K020530
Methodology: https://510kreport.com/methodology