# K090012: Disposable Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Shan Dong Wei Gao Group Medical Polymer Products
- Decided: Jun 11, 2009 after 160 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K060082 (2006). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060082: Tianjin Medis Disposable  Infusion Set, Tianjin Medis International Trade Co., Ltd. (2006) Summary page 2.

## Most influential descendants
- K234129: Ecomed Disposable Administration Sets (2024), 1 descendant of its own
- K254123: Ecomed Disposable Administration Sets (2026), 0 descendants of its own

## Recalls of this device
- Oct 10, 2014 · Class II · Z-1277-2015: Several complaints regarding the IV sets leaking at the Y site.
- Aug 3, 2012 · Class II · Z-2179-2012: Devices leaking at the Y-site

## Indications for use
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/K090012
Methodology: https://510kreport.com/methodology