# K180739: Clearlink System Solution Set

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: May 28, 2019 after 432 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 6 (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.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has 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 5.

## Recalls of this device
- Aug 29, 2025 · Class II · Z-0201-2026: IV sets may leak.
- Aug 29, 2025 · Class II · Z-0203-2026: IV sets may leak.
- Aug 29, 2025 · Class II · Z-0202-2026: IV sets may leak.
- Dec 20, 2024 · Class II · Z-1010-2025: Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
- Dec 20, 2024 · Class II · Z-1009-2025: Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
- Feb 8, 2024 · Class II · Z-1291-2024: Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution set listed below due to potential leaks originating from the drip chamber.

## 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/K180739
Methodology: https://510kreport.com/methodology