# K222766: Disposable Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Ande Healthcare Apparatus Co., Ltd.
- Decided: Apr 12, 2024 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: 3 generations back to K973107 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101958: Amsino I.V. Administration and Extension Sets, Amsino International, Inc. (2010) Summary page 6.

## Indications for use
The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device. The intended populations include adults and pediatrics except neonates.

Source page: https://510kreport.com/device/K222766
Methodology: https://510kreport.com/methodology