# K131646: Disposable Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Jinta Medical Co., Ltd.
- Decided: Nov 26, 2013 after 174 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- 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 K083687 (2009). 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)
- K083687: Baixin Intravascular Administration Set, Anhui Kangda Medical Products Co., Ltd. (2009) Summary page 1.

## Indications for use
JT series Disposable infusion set is used 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/K131646
Methodology: https://510kreport.com/methodology