# K162601: Infusion Set for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Shinva Ande Healthcare Apparatus Co., Ltd.
- Decided: May 31, 2017 after 254 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 K925465 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121803: Intravascular Administration Set, Acta Medical, LLC (2012) Summary page 6.

## Indications for use
The device is indicated for the delivery of fluids from a container to a patient’s vascular system.

Source page: https://510kreport.com/device/K162601
Methodology: https://510kreport.com/methodology