# K140131: Sub-Q Subcutaneous Tissue Infusion Set

- Pathway: 510(k) (Special)
- Applicant: Emed Technologies Corporation
- Decided: Apr 3, 2014 after 76 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: 3 generations back to K831445 (1983). 4 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020530: Evans Sub-Q, Model MC4206, Evans Medical, Inc. (2002) Summary page 1.

## Most influential descendants
- K142319: SCIg60 Infuser, Infuset (2015), 6 descendants of its own
- K161906: SCIg60 Infuser (2016), 5 descendants of its own
- K222087: SCIg60 Infusion System (2022), 3 descendants of its own
- K240148: SCIg60 Infusion System (2024), 1 descendant of its own
- K251105: Tetra (TM-20); Tetra (TM-50) (2025), 0 descendants of its own

## Indications for use
SUB-Q 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/K140131
Methodology: https://510kreport.com/methodology