# K032061: Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH - Pathway: 510(k) (Traditional) - Applicant: Spire Biomedical, Inc. - Decided: Dec 23, 2003 after 173 days - Product code: MSD (Catheter, Hemodialysis, Implanted) - Device class: 2 - Regulation: 21 CFR 876.5540 - Recalls of this device: 48 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 1 generation back to K013160 (2002). 1 ancestor in all. 4 later devices descend from it; 3 cite it directly. 0 of 6 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K013160: Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter, Spire Biomedical, Inc. (2002) Summary page 2. - (no number) Medical Components, Inc. Ash Split Cath: named in the summary without a submission number - (no number) Kendall Healthcare Maxid: named in the summary without a submission number ## Most influential descendants - K042858: 55CM 15.5FR Decathlon Twin Lumen Hemodialysis Catheter W/Separated Tips (2004), 1 descendant of its own - K040509: Alta LR Fixed Tip Chronic Hemodialysis Catheter, Models AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40 (2004), 1 descendant of its own - K073092: Decathlon Twin Lumen Hemodialysis Catheter with Separated Tips, Models DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40, (2008), 0 descendants of its own - K063441: 15.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55 (2007), 0 descendants of its own ## Recalls of this device - Oct 23, 2009 · Not classified · Z-0288-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0289-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0290-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0299-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0301-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0302-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0304-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0306-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0309-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0311-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0312-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0294-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0295-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0296-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0297-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0300-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0303-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0307-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0308-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0314-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0316-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0317-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0318-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0319-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0321-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0330-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0291-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0292-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0293-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0298-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0305-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0310-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0313-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0315-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0320-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0322-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0323-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0324-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0325-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0327-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0328-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0332-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0334-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0335-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0329-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0331-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0333-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi - Oct 23, 2009 · Not classified · Z-0326-2010: There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubi ## Indications for use The 15.5Fr. Decathlon Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown. Source page: https://510kreport.com/device/K032061 Methodology: https://510kreport.com/methodology