Class Class II
Clave™ Neutral-Displacement Needlefree Connectors (K250616)
Description
Clave™ Neutral-Displacement Needlefree Connectors by Icu Medical, Inc., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250616
Clearance Date2025-06-05
Clearance TypeTraditional
Product CodeFPA
Regulation Number880.5440
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250616
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Clave™ Neutral-Displacement Needlefree Connectors (K250616) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212842 | Microvolume Luer Access Device | B.Braun Medical, Inc. | 2022 |
| K100434 | CLAVE NEUTRON | Icu Medical, Inc. | 2010 |
Trace the full predicate network for K250616
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.