# K042182: Y Clave Connector with Integrated Check Valve, Model XI-3432

- Pathway: 510(k) (Special)
- Applicant: Icu Medical, Inc.
- Decided: Sep 1, 2004 after 21 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K080007: Graduated Adapter with Clave (2008), 0 descendants of its own

## Indications for use
The ICU Needleless Connector is a single use sterile, non pyrogenic device intended for use as an accessory to Intravascular Administration Set for the administration of fluids to a patient through a cannula placed In the vein or artery

Source page: https://510kreport.com/device/K042182
Methodology: https://510kreport.com/methodology