# K250616: Clave™ Neutral-Displacement Needlefree Connectors

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Jun 5, 2025 after 97 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
Longest line of descent: 5 generations back to K942988 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100434: Clave Neutron, Icu Medical, Inc. (2010) Summary page 5.

## Indications for use
Clave Neutral-Displacement Connectors (MicroClave ™/ NanoClave ™/ Clave ™Neutron) are intended for the aspiration, injection, or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. Clave Connectors may be used with power injectors at a maximum pressure of 400 psi and a maximum flow rate of 10ml/sec. Clave Connectors will prevent microbial ingress for seven (7) days.

Source page: https://510kreport.com/device/K250616
Methodology: https://510kreport.com/methodology