# K964435: Primary IV Set - Pathway: 510(k) (Traditional) - Applicant: Icu Medical, Inc. - Decided: Apr 2, 1997 after 148 days - Product code: FMG (Stopcock, I.V. Set) - Device class: 2 - Regulation: 21 CFR 880.5440 - Recalls of this device: 188 (5 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; 5 cite it directly. 3 of 18 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) Medical Product Specialists I.V./Secondary Sets: named in the summary without a submission number - (no number) McGaw Intravenous Administration Sets: named in the summary without a submission number - (no number) Churchill Medical Systems IV/Extension Sets: named in the summary without a submission number ## Most influential descendants - K081361: Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXX (2008), 12 descendants of its own - K131549: Chemolock, Chemolock Port (2013), 10 descendants of its own - K141448: Tevadaptor Closed Drug Reconstitution and Transfer System (2015), 9 descendants of its own - K192866: Chemfort CSTD (2020), 3 descendants of its own - K201422: Arisure Closed System Drug Transfer Device (CSTD) (2021), 1 descendant of its own ## Recalls of this device - May 12, 2026 · Class II · Z-3163-2026: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber - May 12, 2026 · Class II · Z-3157-2026: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber - Oct 2, 2025 · Class I · Z-0154-2026: IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unres - Aug 1, 2022 · Class II · Z-1721-2022: Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing. - Dec 2, 2020 · Class II · Z-0955-2021: Due to the incorrect filter assembly. - Dec 2, 2020 · Class II · Z-0956-2021: Due to the incorrect filter assembly. - Dec 2, 2020 · Class II · Z-0957-2021: Due to the incorrect filter assembly. - Dec 2, 2020 · Class II · Z-0958-2021: Due to the incorrect filter assembly. - Jul 6, 2020 · Class II · Z-0207-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0209-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0254-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0242-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0208-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0251-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0184-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0196-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0256-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0222-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0228-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0194-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0186-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0202-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0237-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0243-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0205-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0245-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0241-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0203-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0244-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0190-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0210-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0188-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0253-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0187-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0255-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0211-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0258-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0185-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0223-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0198-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0235-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0191-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0239-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0226-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0227-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0195-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0229-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0206-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0199-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. - Jul 6, 2020 · Class II · Z-0231-2021: Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. ## Indications for use The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein). Source page: https://510kreport.com/device/K964435 Methodology: https://510kreport.com/methodology