# K960581: Secure Eva Dual Chamber Mixing Bag - Pathway: 510(k) (Traditional) - Applicant: Secure Medical Products, Inc. - Decided: Apr 30, 1996 after 78 days - Product code: KPE (Container, I.V.) - Device class: 2 - Regulation: 21 CFR 880.5025 - Recalls of this device: 9 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage No predicates in its family tree. 6 later devices descend from it; 1 cites it directly. 0 of 7 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 - K041038: Churchill Medical Dual Chamber Empty Container (2004), 5 descendants of its own - K121161: Empty Eva Solution Container Empty Eva Dual Chamber Solution Container (2012), 3 descendants of its own - K193528: Empty EVA Bag (2020), 2 descendants of its own - K210749: Empty EVA Bag (2021), 1 descendant of its own - K251139: KabiHelp® Uno; KabiHelp® Advance plus (2026), 0 descendants of its own ## Recalls of this device - Sep 21, 2018 · Class II · Z-0001-2020: Potential for leaking product - Sep 21, 2018 · Class II · Z-0002-2020: Potential for leaking product - Sep 21, 2018 · Class II · Z-0003-2020: Potential for leaking product - Sep 21, 2018 · Class II · Z-0004-2020: Potential for leaking product - Sep 21, 2018 · Class II · Z-0005-2020: Potential for leaking product - Sep 21, 2018 · Class II · Z-0006-2020: Potential for leaking product - Sep 21, 2018 · Class II · Z-0007-2020: Potential for leaking product - Sep 21, 2018 · Class II · Z-0008-2020: Potential for leaking product - Jun 23, 2016 · Class II · Z-2263-2016: An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of Source page: https://510kreport.com/device/K960581 Methodology: https://510kreport.com/methodology