# K221075: Infusion Sets for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Sichuan Prius Biotechnology Co., Ltd.
- Decided: Nov 21, 2022 after 223 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: 1 generation back to K163160 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163160: Sterile Single-use Infusion Set, Jiangxi Hongda Medical Equipment Group, Ltd. (2017) Summary page 5.

## Indications for use
The Infusion Sets for Single Use is intended to administer fluids from a container to a patient’s vascular system through a needle or catheter inserted into the vein.

Source page: https://510kreport.com/device/K221075
Methodology: https://510kreport.com/methodology