# K941190: Clave Needle-Less Connector Open Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Jan 31, 1995 after 323 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K973916: NP Medical Capless Luer Activated Valve (1998), 5 descendants of its own
- K072576: Clearlink Antimicrobial Luer Activated Device (Lad) and Extension Sets with the Clearlink Antimicrobial Luer Activated (2007), 4 descendants of its own
- K081289: V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial Luer Activated Device (2008), 3 descendants of its own
- K030246: Victus I.V. Administration Set, Models 27071 and 27072 (2003), 1 descendant of its own
- K103551: Interlink S / Clearlink System / V-Link Lad with Vitalshield Protective Coating Non-Dehp Catheter Extension Set Kits, (2011), 0 descendants of its own

## Recalls of this device
- Aug 31, 2020 · Class II · Z-0705-2021: Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous me

Source page: https://510kreport.com/device/K941190
Methodology: https://510kreport.com/methodology