# K915571: Clave Connector

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Sep 21, 1992 after 284 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 7 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, 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
- K960661: Maxcess Needle Free Connector (8200) (1996), 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

## Recalls of this device
- Jun 9, 2003 · Not classified · Z-0956-03: The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
- Jun 9, 2003 · Not classified · Z-0955-03: The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
- May 13, 2003 · Not classified · Z-0914-03: IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced.

Source page: https://510kreport.com/device/K915571
Methodology: https://510kreport.com/methodology