# K083687: Baixin Intravascular Administration Set

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Kangda Medical Products Co., Ltd.
- Decided: Jun 11, 2009 after 181 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K131646: Disposable Infusion Set (2013), 0 descendants of its own

## Recalls of this device
- Jan 6, 2016 · Class II · Z-0696-2016: Firm was notified of a potential product defect related to kinking (flattening) of anesthesia extension tubes which may represent a potential health hazard.

## Indications for use
Intravascular Administration Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

Source page: https://510kreport.com/device/K083687
Methodology: https://510kreport.com/methodology