# K112893: Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension Sets

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corporation
- Decided: Oct 18, 2011 after 15 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 8 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003225 (2000). 1 ancestor in all.
11 later devices descend from it; 5 cite it directly.
2 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003225: Solution Administration Sets with Capless Luer Activated Valve, Baxter Healthcare Corp (2000) Summary page 2.

## Most influential descendants
- K203609: Intravascular Administration Sets (2021), 4 descendants of its own
- K192366: Intravascular Extension Sets and Accessories (2020), 2 descendants of its own
- K243529: Solution Administration Sets (2025), 0 descendants of its own
- K242339: Intravascular Extension Sets and Accessories (2025), 0 descendants of its own
- K221121: Volumat Polyethylene I.V. Administration Set (2023), 0 descendants of its own

## Recalls of this device
- Aug 29, 2025 · Class II · Z-0190-2026: IV sets may leak.
- Aug 29, 2025 · Class II · Z-0191-2026: IV sets may leak.
- Aug 29, 2025 · Class II · Z-0197-2026: IV sets may leak.
- Aug 29, 2025 · Class II · Z-0198-2026: IV sets may leak.
- Aug 29, 2025 · Class II · Z-0199-2026: IV sets may leak.
- Aug 9, 2022 · Class I · Z-1653-2022: Firm noted an increase in customer reports of leaks.
- Sep 4, 2013 · Class II · Z-0099-2014: The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinholes are a breach in the sterile barrier and could lead to potential contamination.
- Mar 28, 2013 · Class II · Z-1271-2013: Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.

## Indications for use
For use with a vascular access device for the administration of drugs and solutions. The Clearlink Luer Activated Valve is an in-line injection site, which can be connected to standard male Luer adapters (e.g., syringes or sets) for continuous or intermittent fluid administration or the withdrawal of fluids.

Source page: https://510kreport.com/device/K112893
Methodology: https://510kreport.com/methodology