# K202437: Infusion Sets for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Suyun Medical Materials Co., Ltd.
- Decided: Mar 25, 2022 after 577 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 device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The maximum use time of the infusion sets shall not exceed 24 hours. The intravenous infusion needle should be used for only single dose administration and not to be left in place for more than 2 hours.

Source page: https://510kreport.com/device/K202437
Methodology: https://510kreport.com/methodology