# K203609: Intravascular Administration Sets

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Sep 30, 2021 after 294 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003225 (2000). 2 ancestors in all.
4 later devices descend from it; 4 cite it directly.
2 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112893: Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension Sets, Baxter Healthcare Corporation (2011) Summary page 4.

## Most influential descendants
- K243529: Solution Administration Sets (2025), 0 descendants of its own
- K221121: Volumat Polyethylene I.V. Administration Set (2023), 0 descendants of its own
- K220301: Volumat Line (2023), 0 descendants of its own
- K220312: Polyfusion IV Administration Sets (2023), 0 descendants of its own

## Recalls of this device
- Aug 29, 2025 · Class II · Z-0193-2026: IV sets may leak.
- Aug 29, 2025 · Class II · Z-0194-2026: IV sets may leak.
- Aug 29, 2025 · Class II · Z-0192-2026: IV sets may leak.
- Aug 8, 2025 · Class II · Z-2594-2025: Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.
- Dec 20, 2024 · Class II · Z-1011-2025: Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.

## 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/K203609
Methodology: https://510kreport.com/methodology