# K243529: Solution Administration Sets

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Mar 14, 2025 after 120 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003225 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
2 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203609: Intravascular Administration Sets, Baxter Healthcare Corporation (2021) Summary page 6.

## Recalls of this device
- Jun 30, 2026 · Class I · Z-2766-2026: Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.

## Indications for use
For the administration of fluids from a container into the patient’s vascular system through a vascular access device.

Source page: https://510kreport.com/device/K243529
Methodology: https://510kreport.com/methodology