# K081113: Cook and Cook Spectrum Central Venous Catheters - Pathway: 510(k) (Traditional) - Applicant: Cook, Inc. - Decided: Jul 30, 2008 after 103 days - Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days) - Device class: 2 - Regulation: 21 CFR 880.5200 - Recalls of this device: 105 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 4 generations back to K960764 (1997). 9 ancestors in all. 31 later devices descend from it; 3 cite it directly. 1 of 41 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K033843: Spectrum Central Venous Catheter with or Without Hydrophilic Coating, Cook, Inc. (2004) Summary page 1. - K032274: Cook Five Lumen Central Venous Catheter, Cook, Inc. (2004) Summary page 1. - K060174: Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-Abrm, Cook, Inc. (2006) Summary page 1. ## Most influential descendants - K101326: NMI IC (2010), 26 descendants of its own - K121089: Nmi Picc Iii (2012), 23 descendants of its own - K111906: Xcela Hybrid Picc with Pasv Valve Technology (2011), 14 descendants of its own - K122882: Nmi Hpicc Iii (2012), 12 descendants of its own - K131942: Nmi Picc Iii Catheter, Nmi Hpicc Iii Catheter (2013), 7 descendants of its own ## Recalls of this device - Mar 5, 2026 · Class II · Z-1783-2026: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. - Mar 5, 2026 · Class II · Z-1789-2026: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. - Mar 5, 2026 · Class II · Z-1788-2026: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. - Oct 4, 2010 · Not classified · Z-1198-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1123-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1099-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1112-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1119-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1153-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1212-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1173-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1166-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1201-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1216-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1171-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1163-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1131-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1205-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1152-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1154-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1125-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1098-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1180-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1194-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1127-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1203-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1169-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1151-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1164-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1137-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1196-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1142-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1211-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1105-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1147-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1174-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1149-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1114-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1110-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1145-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1141-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1214-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1162-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1202-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1161-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1192-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1159-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1111-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1155-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays - Oct 4, 2010 · Not classified · Z-1121-2011: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays ## Indications for use The Cook Central Venous Catheter is used for: * Continuous or intermittent drug infusions * Central venous blood pressure monitoring (CVP) * Acute hyperalimentation * Blood sampling * Delivery of whole blood or blood products * Power injection of contrast media* The device is a short-term use catheter. * The flow rate of the Cook Central Venous Catheters may not exceed 10 ml/sec. The Cook Spectrum and Spectrum Glide Central Venous Catheter is used for: * Continuous or intermittent drug infusions * Central venous blood pressure monitoring (CVP) * Acute hyperalimentation * Blood sampling * Delivery of whole blood or blood products * Power injection of contrast media* The activity of the antimicrobial agents, minocycline and rifampin, is localized at the internal and external catheter surface and helps to provide protection against catheter-related bloodstream infections (CRBSI). It is not intended for treatment of existing infection. The device is a short-term use catheter. * The flow rate of the Cook Central Venous Catheters may not exceed 10 ml/sec. Source page: https://510kreport.com/device/K081113 Methodology: https://510kreport.com/methodology