# K083723: A6 Luer Access Device - Pathway: 510(k) (Traditional) - Applicant: B.Braun Medical, Inc. - Decided: Jun 5, 2009 after 172 days - Product code: FPA (Set, Administration, Intravascular) - Device class: 2 - Regulation: 21 CFR 880.5440 - Recalls of this device: 66 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 3 generations back to K942988 (1995). 3 ancestors in all. 31 later devices descend from it; 2 cite it directly. 0 of 35 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K031923: Ultrasite Valve, B.Braun Medical, Inc. (2003) - K955585: V2 Injection Site, B.Braun Medical, Inc. (1996) Summary page 1. ## Most influential descendants - K100434: Clave Neutron (2010), 28 descendants of its own - K132413: MZ1000 (2013), 26 descendants of its own - K140831: Maxzero Extension Set with Needless Connector (2014), 13 descendants of its own - K170336: BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector (2017), 6 descendants of its own - K183399: BD Nexiva Closed IV Catheter System (2019), 5 descendants of its own ## Recalls of this device - Oct 29, 2025 · Class II · Z-0691-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0703-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0685-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0661-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0695-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0660-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0684-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0619-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0676-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0652-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0653-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0615-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0658-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0688-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0612-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0698-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0664-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0690-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0624-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0716-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0692-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0693-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0633-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0699-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0654-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0627-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0622-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0657-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0656-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0625-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0662-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0659-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0689-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0616-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0694-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0663-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0683-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0617-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0687-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0607-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0696-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0628-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0715-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0610-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0706-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0704-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0614-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0609-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0655-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Oct 29, 2025 · Class II · Z-0626-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). ## Indications for use The A6 Luer Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The A6 Luer Access Device may be used with power injectors at a maximum pressure of 300 psi and a maximum flow rate of 10 ml/sec. Source page: https://510kreport.com/device/K083723 Methodology: https://510kreport.com/methodology