# K131549: Chemolock, Chemolock Port - Pathway: 510(k) (Traditional) - Applicant: Icu Medical, Inc. - Decided: Jul 26, 2013 after 58 days - Product code: ONB (Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System) - Device class: 2 - Regulation: 21 CFR 880.5440 - Recalls of this device: 60 (2 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 7 generations back to K883614 (1988). 31 ancestors in all. 10 later devices descend from it; 1 cites it directly. 3 of 42 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K123213: BD Phaseal Closed System Transfer Device, Becton, Dickinson & CO (2013) Summary page 1. - K081361: Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXX, Icu Medical, Inc. (2008) Summary page 1. - K082806: Spinning Spiros, Model CH-2000, Icu Medical, Inc. (2009) Summary page 1. ## Most influential descendants - 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 - K180489: TEVADAPTOR Closed Drug Reconstitution and Transfer System (2018), 1 descendant of its own - K253033: Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor (2025), 0 descendants of its own ## Recalls of this device - May 12, 2026 · Class II · Z-3159-2026: 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-3161-2026: 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 - Mar 24, 2026 · Class II · Z-2210-2026: Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in t - Sep 8, 2025 · Class II · Z-0340-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0352-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0333-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0336-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0343-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0358-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0348-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0347-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0341-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0335-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0357-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0351-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0342-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0356-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0344-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0350-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0354-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0360-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0359-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0346-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0338-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0361-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0362-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0329-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0337-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0330-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0349-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0328-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0353-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0339-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0365-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0334-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0355-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0345-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0331-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0364-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0363-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Sep 8, 2025 · Class II · Z-0332-2026: Port weld of drug transfer device may separate or break during use and potentially result in a leak. - Nov 6, 2024 · Class II · Z-0652-2025: Due to finished goods incorrectly packaged and labeled. - Jun 27, 2022 · Class II · Z-1681-2022: Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and expo - Mar 16, 2021 · Class II · Z-1574-2021: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. - Mar 16, 2021 · Class II · Z-1572-2021: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. - Mar 16, 2021 · Class II · Z-1575-2021: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. - Mar 16, 2021 · Class II · Z-1571-2021: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. - Mar 16, 2021 · Class II · Z-1570-2021: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. - Mar 16, 2021 · Class II · Z-1573-2021: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. - Aug 31, 2020 · Class II · Z-0703-2021: Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous me ## Indications for use The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel. Source page: https://510kreport.com/device/K131549 Methodology: https://510kreport.com/methodology