# K142036: Infusomat Space Volumetric Infusion Pump Administration Sets - Pathway: 510(k) (Special) - Applicant: B.Braun Medical, Inc. - Decided: Aug 25, 2014 after 28 days - Product code: FPA (Set, Administration, Intravascular) - Device class: 2 - Regulation: 21 CFR 880.5440 - Recalls of this device: 31 (2 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 4 generations back to K904518 (1990). 19 ancestors in all. 1 later device descends from it; 1 cites it directly. 4 of 21 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K062700: Infusomat Space Volumetric Infusion Pump System, B.Braun Medical, Inc. (2006) Summary page 4. ## Most influential descendants - K243392: Infusomat® Space Volumetric Infusion Pump Administration Sets (2025), 0 descendants of its own ## Recalls of this device - Oct 29, 2025 · Class II · Z-0640-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). - Jun 17, 2024 · Class II · Z-2384-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2378-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2403-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2388-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2386-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2383-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2399-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2393-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2401-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2389-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2398-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2379-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2385-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2392-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2381-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2397-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2382-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2387-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2394-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2391-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2380-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2402-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2390-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2400-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2396-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Jun 17, 2024 · Class II · Z-2395-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie - Nov 1, 2023 · Class I · Z-0355-2024: In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt - Jun 25, 2021 · Class II · Z-2137-2021: There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp pr - May 1, 2019 · Class I · Z-2489-2019: Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site). - May 9, 2018 · Class II · Z-2285-2018: There is a potential for a different set to be mixed within the lot, where the incorrect set does not contain an air eliminating filter. ## Indications for use The Infusomat® Space Volumetric Pump Administration Sets are intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral and enteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, intra-arterial, subcutaneous, epidural, irrigation/ablation, and enteral. The sets are used for the delivery of medications indicated for infusion therapy including but not limited to drugs like anesthetics, sedatives, analgesics, catecholamines, anticoagulants etc., blood and blood components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The Infusomat Space Volumetric Pump Administration Sets are intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments. Source page: https://510kreport.com/device/K142036 Methodology: https://510kreport.com/methodology