# K033843: Spectrum Central Venous Catheter with or Without Hydrophilic Coating

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Aug 12, 2004 after 246 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: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K950118 (1996). 1 ancestor in all.
33 later devices descend from it; 2 cite it directly.
1 of 35 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950118: Abrm Catheter, Cook, Inc. (1996) Summary page 1.

## Most influential descendants
- K060174: Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-Abrm (2006), 32 descendants of its own
- K081113: Cook and Cook Spectrum Central Venous Catheters (2008), 31 descendants of its own
- 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

## Recalls of this device
- 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.
- Mar 6, 2020 · Class II · Z-1566-2020: The printed expiration dates are incorrect.
- Jul 31, 2017 · Class II · Z-0634-2018: Central venous catheters may not fit over guide wire potentially causing procedure delay.
- Nov 28, 2016 · Class II · Z-0733-2017: Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle. Potential adverse events that
- Oct 4, 2010 · Not classified · Z-1157-2011: 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-1107-2011: 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-1106-2011: 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-1158-2011: 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-1109-2011: 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-1108-2011: 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 Spectrum® Central Venous Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSI). It is not intended to be used as treatment for existing infections. The device is a short-term use catheter, supplied sterile and intended for one-time use.

Source page: https://510kreport.com/device/K033843
Methodology: https://510kreport.com/methodology