# K201626: Safety Subcutaneous Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Epic Medical Pte., Ltd.
- Decided: Mar 24, 2021 after 281 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: 4 generations back to K831445 (1983). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140131: Sub-Q Subcutaneous Tissue Infusion Set, Emed Technologies Corporation (2014) Summary page 4.

## Indications for use
The Safety Subcutaneous Infusion Set is indicated for subcutaneous infusion of medication administered by an external infusion pump or syringe.

Source page: https://510kreport.com/device/K201626
Methodology: https://510kreport.com/methodology