# K970855: Clave Connector - Pathway: 510(k) (Traditional) - Applicant: Icu Medical, Inc. - Decided: Jun 24, 1997 after 106 days - Product code: FPA (Set, Administration, Intravascular) - Device class: 2 - Regulation: 21 CFR 880.5440 - Recalls of this device: 52 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage No predicates in its family tree. 82 later devices descend from it; 15 cite it directly. 2 of 83 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - None. The FDA summary names its predicate without a number. - (no number) IVAC SmartSite™: named in the summary without a submission number ## Most influential descendants - K973167: Positive Pressure Connector (1997), 35 descendants of its own - K991653: Invision-Plus Injection Port Connector System (1999), 31 descendants of its own - K021692: CLC2000 Catheter Patency Device (2003), 29 descendants of its own - K120443: Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated Device (2012), 28 descendants of its own - K100434: Clave Neutron (2010), 28 descendants of its own ## Recalls of this device - Aug 1, 2022 · Class II · Z-1722-2022: Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing. - Dec 24, 2013 · Class II · Z-0697-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0674-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0689-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0694-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0670-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0682-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0661-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0663-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0707-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0702-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0686-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0668-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0671-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0692-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0678-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0695-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0687-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0673-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0706-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0699-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0700-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0675-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0664-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0704-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0705-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0684-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0667-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0690-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0685-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0703-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0669-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0672-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0666-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0677-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0691-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0681-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0701-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0683-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0696-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0688-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0659-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0693-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0698-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0679-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0662-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0658-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0660-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0676-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. - Dec 24, 2013 · Class II · Z-0665-2014: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. ## Indications for use The ICU Needleless Conngector 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/K970855 Methodology: https://510kreport.com/methodology